FDA product code · Hematology
KITMedia And Components, Synthetic Cell And Tissue Culture
Product code KIT covers Media And Components, Synthetic Cell And Tissue Culture, a Class I device regulated under 21 CFR 864.2220. FDA has cleared 367 devices in this code. Median review time across the 367 most recent decisions is 20 days. openFDA lists 4 recall records against this code.
Updated · ingest status · JSON
- Class
- Class I
- Regulation
- 21 CFR 864.2220
- Review panel
- Hematology
- Clearances
- 367
What is happening in KIT right now?
KIT (Media And Components, Synthetic Cell And Tissue Culture): nothing changed in the six FDA sources we watch.
Checked predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Nothing changed, so there is nothing here — which is the point. We only write when something did.
How many devices has FDA cleared in KIT?
FDA has cleared 367 devices under product code KIT since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K892938 | AMNIO-GROW TM | Inovar Biologicals, Inc. | |
| K890701 | ENDOTHELIAL GROWTH MEDIUM (EGM) | Clonetics Corp. | |
| K890700 | MELANOCYTE GROWTH MEDIUM (MGM) | Clonetics Corp. | |
| K890482 | ABC, ABC-1X, ABC(TM) | Cell Ent., Inc. | |
| K884654 | ALPHACALF SERUM | Hyclone Laboratories, Inc. | |
| K884574 | DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785 | Sigma Chemical Co. | |
| K884573 | HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891 | Sigma Chemical Co. | |
| K884572 | RPMI-1640 HYBRI-MAX, PROD. NO. R5382 | Sigma Chemical Co. | |
| K883065 | ALLOPREP SYSTEM | Osteotech, Inc. | |
| K884031 | FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT | Regency Biotech |
How long does FDA review take for KIT?
The median FDA review time for KIT is 20 days, measured across the 367 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in KIT?
openFDA lists 4 recall records against product code KIT. A recall record covers one firm's corrective action and may span many device lots.
Z-0171-2019TerminatedLife Technologies Corporation
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
Z-0172-2019TerminatedLife Technologies Corporation
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
Z-0173-2019TerminatedLife Technologies Corporation
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
Z-0174-2019TerminatedLife Technologies Corporation
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for KIT?
MAUDE holds no adverse-event reports naming product code KIT.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
What are the predicate devices in KIT?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in KIT?
Across the 367 most recent decisions, these applicants filed most often in KIT.
| Applicant | Recent clearances |
|---|---|
| J R Scientific | 132 |
| Sigma Chemical Co. | 87 |
| Dutchland Laboratories, Inc. | 42 |
| Hazleton Research Products, Inc. | 34 |
| Mediatech, Inc. | 23 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch KIT
Get an email the morning anything changes in KIT — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.