Medical device manufacturer
Medical Analysis Systems, Inc.
Medical Analysis Systems, Inc. holds 107 FDA 510(k) clearances across 38 product codes. Median elapsed review time is 30 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 107
- Product codes
- 38
- Median review
- 30 days
- Recall records
- 0
How does FDA spell Medical Analysis Systems, Inc.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Medical Analysis Systems, Inc. file in?
38 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 31 | 33 days | |
| DIF | Drug Mixture Control Materials | 13 | 49 days | |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 6 | 19 days | |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 5 | 36 days | |
| CEK | Biuret (Colorimetric), Total Protein | 3 | 23 days | |
| CFR | Hexokinase, Glucose | 3 | 23 days | |
| CIG | Diazo Colorimetry, Bilirubin | 3 | 41 days | |
| JJT | Enzyme Controls (Assayed And Unassayed) | 3 | 29 days | |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 | 29 days | |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 2 | 23 days | |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 | 23 days | |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 2 | 22 days | |
| JFJ | Catalytic Methods, Amylase | 2 | 65 days | |
| JGJ | Photometric Method, Magnesium | 2 | 18 days | |
| JIT | Calibrator, Secondary | 2 | 17 days | |
| JMK | Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase | 2 | 23 days | |
| MSJ | Apolipoproteins | 2 | 21 days | |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 72 days | |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 16 days | |
| CET | Olive Oil Emulsion (Turbidimetric), Lipase | 1 | 95 days | |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 23 days | |
| CFM | Bathophenanthroline, Colorimetry, Iron (Non-Heme) | 1 | 43 days | |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 24 days | |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 1 | 38 days | |
| CHS | Coulometric Method, Carbon-Dioxide | 1 | 50 days |
Showing the 25 they file in most, of 38.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Medical Analysis Systems, Inc. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Medical Analysis Systems, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K042717 | MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL | JJX | 36 | |
| K041194 | ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H | JJX | 102 | |
| K040880 | MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 | JJY | 23 | |
| K032826 | MAS PAR TDM | DIF | 29 | |
| K032335 | MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL | JJY | 21 | |
| K031890 | MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL | JJX | 28 | |
| K031441 | URICHEMTRAK LIQUID ASSAYED URINE CONTROL | JJW | 56 | |
| K031392 | MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL | DKC | 60 | |
| K031364 | MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 | JJY | 30 | |
| K030942 | MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL | JJY | 33 |
Source: openFDA device/510k · retrieved
Watch what Medical Analysis Systems, Inc. files next
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