Rapid Diagnostic Laboratories, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Rapid Diagnostic Laboratories, Inc.” (first 1985, latest 1990), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 68 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 |
|---|---|---|---|
| DIF | Drug Mixture Control Materials | 3 | 3 |
| DKB | Calibrators, Drug Mixture | 1 | 1 |
| KRJ | Filter, Prebypass, Cardiopulmonary Bypass | 1 | 1 |
| LAS | Drug Specific Control Materials | 1 | 1 |
Review panels
Most recent Rapid Diagnostic Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K903909 | BLIND CONTROLS FOR DRUGS OF ABUSE TESTING | DIF | 1990-10-26 | 65 |
| K890030 | NEW LOW LEVEL DRUG MIXTURE CONTROL | DIF | 1989-01-23 | 19 |
| K875216 | HIGH PERFORMANCE CALIBRATORS | DKB | 1988-06-22 | 183 |
| K871694 | HYPERFORMANCE CONTROLS (HP-CONTROLS) | DIF | 1987-07-07 | 70 |
| K863117 | HIGH PERFORMANCE CANNABINOID CONTROLS | LAS | 1986-09-25 | 42 |
| K850139 | COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER | KRJ | 1985-04-10 | 86 |
Recalls
openFDA lists no recalls under a recalling firm named Rapid Diagnostic Laboratories, 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.
- Rapid City Regional Hospital, Inc. (10 510(k)s)
- Rapid Medical Ltd. (7 510(k)s)
- Rapid Biomedical GmbH (7 510(k)s)
- Rapid Diagnostics, Inc. (4 510(k)s)
- Rapid Aid Corp. (3 510(k)s)
- Rapid Pathogen Screening, Inc. (3 510(k)s)
- Rapid Injection Systems Corp. (2 510(k)s)
- Rapid Reboot Recovery Products, LLC (2 510(k)s)
- Rapid Machine & Tool Corp. (1 510(k)s)
- Rapid Mfg. Co. (1 510(k)s)
- Rapid Nexus Nanotech Wound Solutions, Inc. (1 510(k)s)
- Rapid Response Solutions, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Rapid Diagnostic Laboratories, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Rapid Diagnostic Laboratories, Inc.” (first 1985, latest 1990), across 4 product codes in 2 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 Rapid Diagnostic Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rapid Diagnostic Laboratories, Inc. is 68 days.
Which FDA product codes appear under Rapid Diagnostic Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are DIF (Drug Mixture Control Materials, 3); DKB (Calibrators, Drug Mixture, 1); KRJ (Filter, Prebypass, Cardiopulmonary Bypass, 1).
Next steps
- See all 6 Rapid Diagnostic Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DIF, Rapid Diagnostic Laboratories, 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.