Medical device manufacturer
Roche Diagnostic Systems, Inc.
Roche Diagnostic Systems, Inc. holds 296 FDA 510(k) clearances across 118 product codes. Median elapsed review time is 66 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 296
- Product codes
- 118
- Median review
- 66 days
- Recall records
- 0
How does FDA spell Roche Diagnostic 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 Roche Diagnostic Systems, Inc. file in?
118 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | 17 | 51 days | |
| DIF | Drug Mixture Control Materials | 14 | 37 days | |
| LAS | Drug Specific Control Materials | 14 | 54 days | |
| LDJ | Enzyme Immunoassay, Cannabinoids | 11 | 45 days | |
| DKB | Calibrators, Drug Mixture | 10 | 48 days | |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 9 | 54 days | |
| JIX | Calibrator, Multi-Analyte Mixture | 9 | 70 days | |
| DLJ | Calibrators, Drug Specific | 8 | 63 days | |
| JXM | Enzyme Immunoassay, Benzodiazepine | 7 | 24 days | |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 6 | 109 days | |
| DIS | Enzyme Immunoassay, Barbiturate | 6 | 27 days | |
| DJG | Enzyme Immunoassay, Opiates | 5 | 50 days | |
| JJG | Analyzer, Chemistry, Centrifugal, For Clinical Use | 4 | 54 days | |
| KLN | Radioimmunoassay, Cocaine Metabolite | 4 | 22 days | |
| KNK | Acid, Uric, Uricase (Colorimetric) | 4 | 88 days | |
| LAT | Radioimmunoassay, Cannabinoid(S) | 4 | 61 days | |
| LCM | Enzyme Immunoassay, Phencyclidine | 4 | 24 days | |
| LCP | Assay, Glycosylated Hemoglobin | 4 | 149 days | |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 3 | 135 days | |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 3 | 109 days | |
| CIG | Diazo Colorimetry, Bilirubin | 3 | 71 days | |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 3 | 59 days | |
| DJP | Radioimmunoassay, Amphetamine | 3 | 66 days | |
| DLB | Radioimmunoassay, Lsd (125-I) | 3 | 59 days | |
| DOE | Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. | 3 | 143 days |
Showing the 25 they file in most, of 118.
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 Roche Diagnostic 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 Roche Diagnostic Systems, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K983698 | MODIFICATION TO ABUSCREEN ONLINE BARBITURATES | DIS | 194 | |
| K983702 | MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES | JXM | 113 | |
| K983704 | MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE | JCM | 112 | |
| K983556 | ABUSCREEN ONLINE BENZ 300 CALIBRATORS | DLJ | 63 | |
| K983555 | ABUSCREEN ONLINE BENZ 200 CALIBRATORS | DLJ | 63 | |
| K983703 | MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE | DJR | 51 | |
| K983701 | MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS | LDJ | 51 | |
| K983700 | MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE | JXN | 51 | |
| K983699 | MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES | DKZ | 51 | |
| K983697 | MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE | DIO | 51 |
Source: openFDA device/510k · retrieved
Watch what Roche Diagnostic Systems, Inc. files next
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