Medical Laboratory Automation Systems, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Medical Laboratory Automation Systems, Inc.” (first 1978, latest 1996), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 77 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 |
|---|---|---|---|
| GKP | Instrument, Coagulation, Automated | 5 | 5 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 4 | 4 |
| LIO | Device, Specimen Collection | 3 | 3 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 2 | 2 |
| GJA | Test, Thrombin Time | 1 | 1 |
| JTX | Transport Systems, Anaerobic | 1 | 1 |
| KQG | Instrument, Coagulation | 1 | 1 |
Review panels
- Hematology (11)
- Microbiology (4)
- Clinical Chemistry (2)
Most recent Medical Laboratory Automation Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962664 | ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER | GKP | 1996-09-10 | 63 |
| K944227 | ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER | GKP | 1995-02-03 | 155 |
| K931206 | ELECTRA 1600C AUTOMATIC COAGULATION TIMER | GKP | 1993-08-23 | 166 |
| K923220 | THROMBIN CLOT TIME TEST PROCEDURE | GJA | 1992-09-29 | 90 |
| K903638 | GASTRO-INTESTINAL ACCU-CULSHURE TM | LIO | 1991-01-18 | 158 |
| K903406 | VIRAL ACCU-CULSHURE TM | LIO | 1990-10-16 | 77 |
| K903405 | CHLAMYDIA ACCU-CULSHURE TM | LIO | 1990-10-16 | 77 |
| K901645 | ANAEROBIC ACCU-CULSHURE(TM) | JTX | 1990-07-16 | 98 |
| K894052 | ELECTRA 1000C AUTOMATIC COAGULATION TIMER | GKP | 1989-07-27 | 50 |
| K884863 | ELECTRA 900C AUTOMATIC COAGULATION TIMER | GKP | 1989-02-03 | 74 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medical Laboratory Automation 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.
- Medical Analysis Systems, Inc. (107 510(k)s)
- Medical Components, Inc. (63 510(k)s)
- Medical Advances, Inc. (57 510(k)s)
- Medical Diagnostic Technologies, Inc. (57 510(k)s)
- Medical Devices, Inc. (49 510(k)s)
- Medical Device Technologies, Inc. (46 510(k)s)
- Medical Specialties, Inc. (40 510(k)s)
- Medical Device Inspection Co., Inc. (30 510(k)s)
- Medical Engineering Corp. (28 510(k)s)
- Medical Data Electronics (27 510(k)s)
- Medical Graphics Corp. (25 510(k)s)
- Medical Innovations Corp. (24 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medical Laboratory Automation Systems, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Medical Laboratory Automation Systems, Inc.” (first 1978, latest 1996), across 7 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 Medical Laboratory Automation Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Laboratory Automation Systems, Inc. is 77 days.
Which FDA product codes appear under Medical Laboratory Automation Systems, Inc.?
The most frequent FDA product codes under this applicant name are GKP (Instrument, Coagulation, Automated, 5); JPA (System, Multipurpose For In Vitro Coagulation Studies, 4); LIO (Device, Specimen Collection, 3).
Next steps
- See all 17 Medical Laboratory Automation Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GKP, Medical Laboratory Automation 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.