Analytical Control Systems, Inc.: FDA filings under this applicant name
FDA lists 42 510(k) clearances under the applicant name “Analytical Control Systems, Inc.” (first 1979, latest 1997), across 14 product codes in 3 review panels. Median 510(k) review time under this name: 50 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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) | 10 | 10 |
| GFO | Activated Partial Thromboplastin | 5 | 5 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 5 | 5 |
| GGC | Control, Plasma, Abnormal | 4 | 4 |
| GJS | Test, Time, Prothrombin | 4 | 4 |
| DIF | Drug Mixture Control Materials | 3 | 3 |
| GIZ | Plasma, Control, Normal | 2 | 2 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | 2 |
| LCP | Assay, Glycosylated Hemoglobin | 2 | 2 |
| JIS | Calibrator, Primary | 1 | 1 |
Plus 4 more product codes.
Review panels
- Clinical Chemistry (19)
- Hematology (19)
- Clinical Toxicology (4)
Most recent Analytical Control Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961892 | SPECKTIN-LA TEST SET | GFO | 1997-03-07 | 295 |
| K941115 | ACS CARDIO-TROL CONTROL | JJY | 1994-07-20 | 135 |
| K940272 | ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL | JJX | 1994-04-20 | 98 |
| K940397 | ACS O DILVENT PROTEIN DILUTION MATRIX | JJY | 1994-03-11 | 43 |
| K930477 | ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR | JIS | 1993-06-07 | 129 |
| K926012 | ACS APCT REAGENT, MODIFIED | GFO | 1993-04-27 | 158 |
| K925340 | COAGULATION CONTROL CONTAINING HEMOGLOBIN | JPA | 1993-03-23 | 154 |
| K925906 | NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL | JJX | 1993-02-18 | 90 |
| K921223 | ACS FREEZE-DRIED APTT REAGENT | GFO | 1992-08-18 | 158 |
| K921118 | ACS APCT REAGENT | GFO | 1992-07-28 | 141 |
32 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Analytical Control Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Analytical Products, Inc. (57 510(k)s)
- Analytical & Research Chemicals, Inc. (12 510(k)s)
- Analytical Industries, Inc. (3 510(k)s)
- Analytical Luminescence Laboratory, Inc. (2 510(k)s)
- Analytical Development Assoc. Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Analytical Control Systems, Inc.?
FDA lists 42 510(k) clearances under the applicant name “Analytical Control Systems, Inc.” (first 1979, latest 1997), across 14 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Analytical Control Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Analytical Control Systems, Inc. is 50 days.
Which FDA product codes appear under Analytical Control Systems, Inc.?
The most frequent FDA product codes under this applicant name are JJY (Multi-Analyte Controls, All Kinds (Assayed), 10); GFO (Activated Partial Thromboplastin, 5); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 5).
Next steps
- See all 42 Analytical Control Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJY, Analytical Control Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.