Medical Analysis Systems, Inc.: FDA clearances and approvals
Medical Analysis Systems, Inc. has 107 FDA 510(k) clearances (first 1978, latest 2004), across 39 product codes in 4 review panels. Median 510(k) review time: 30 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 31 | 31 |
| DIF | Drug Mixture Control Materials | 13 | 13 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 6 | 6 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 5 | 5 |
| CEK | Biuret (Colorimetric), Total Protein | 3 | 3 |
| CFR | Hexokinase, Glucose | 3 | 3 |
| CIG | Diazo Colorimetry, Bilirubin | 3 | 3 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 3 | 3 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 | 2 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 2 | 2 |
Plus 29 more product codes.
Review panels
- Clinical Chemistry (89)
- Clinical Toxicology (14)
- Hematology (2)
- Immunology (1)
Most recent Medical Analysis Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042717 | MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL | JJX | 2004-11-05 | 36 |
| K041194 | ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H | JJX | 2004-08-16 | 102 |
| K040880 | MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 | JJY | 2004-04-28 | 23 |
| K032826 | MAS PAR TDM | DIF | 2003-10-09 | 29 |
| K032335 | MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL | JJY | 2003-08-19 | 21 |
| K031890 | MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL | JJX | 2003-07-16 | 28 |
| K031441 | URICHEMTRAK LIQUID ASSAYED URINE CONTROL | JJW | 2003-07-01 | 56 |
| K031392 | MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL | DKC | 2003-07-01 | 60 |
| K031364 | MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 | JJY | 2003-05-30 | 30 |
| K030942 | MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL | JJY | 2003-04-28 | 33 |
97 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medical Analysis Systems, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Medical Analysis Systems, Inc. have?
Medical Analysis Systems, Inc. has 107 FDA 510(k) clearances (first 1978, latest 2004), across 39 product codes in 4 review panels.
How long does FDA take to clear Medical Analysis Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Medical Analysis Systems, Inc.'s cleared 510(k)s is 30 days.
What devices does Medical Analysis Systems, Inc. make?
Its most frequent FDA product codes are JJY (Multi-Analyte Controls, All Kinds (Assayed), 31); DIF (Drug Mixture Control Materials, 13); JJW (Urinalysis Controls (Assayed And Unassayed), 6).
Has Medical Analysis Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medical Analysis Systems, Inc. Related entities may recall under other names.
Next steps
- See all 107 Medical Analysis Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJY, Medical Analysis Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.