Laboratory Products, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Laboratory Products, Inc.” (first 1979, latest 1983), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 40 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 |
|---|---|---|---|
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 1 | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
| GIF | Diluent, Blood Cell | 1 | 1 |
| ICL | Carbol Fuchsin | 1 | 1 |
| IFI | Sprays, Synthetic, Smear | 1 | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 | 1 |
| JSJ | Culture Media, Selective And Non-Differential | 1 | 1 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 1 | 1 |
Review panels
- Clinical Chemistry (3)
- Microbiology (2)
- Pathology (2)
- Hematology (1)
Most recent Laboratory Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K832588 | CIN AGAR | JSJ | 1983-09-12 | 41 |
| K803051 | FLAME PHOTOMETRY REAGENTS | JIX | 1981-01-09 | 38 |
| K803013 | CHLORIDE/TCO2 ANALYZER REAGENTS | CHJ | 1981-01-02 | 35 |
| K803050 | SPRAY, SYNTHETIC SMEAR | IFI | 1980-12-30 | 28 |
| K800180 | VARIOUS REAGENTS FOR BLOOD CELL ANALYZER | GIF | 1980-03-19 | 50 |
| K792482 | CHEMISTRY ANALYZER REAGENTS | CIX | 1980-01-11 | 53 |
| K792481 | CULTURE PLATES & TUBED MEDIA | JTZ | 1979-12-31 | 42 |
| K792483 | STAINS, COUNTERSTAINS & GEN. PURPOSE | ICL | 1979-12-18 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Laboratory Products, 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.
- Laboratory Data Control (4 510(k)s)
- Laboratory Technologies, Inc. (4 510(k)s)
- Laboratory Diagnostics Co., Inc. (2 510(k)s)
- Laboratory Equipment Corp. (2 510(k)s)
- Laboratory and Medical Products Group (1 510(k)s)
- Laboratory Corporation of America Holdings (1 510(k)s)
- Laboratory Equipment Design Co. (1 510(k)s)
- Laboratory For Applied Immunology, Inc. (1 510(k)s)
- Laboratory & Specialty Gases, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Laboratory Products, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Laboratory Products, Inc.” (first 1979, latest 1983), across 8 product codes in 4 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 Laboratory Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Laboratory Products, Inc. is 40 days.
Which FDA product codes appear under Laboratory Products, Inc.?
The most frequent FDA product codes under this applicant name are CHJ (Mercuric Thiocyanate, Colorimetry, Chloride, 1); CIX (Bromcresol Green Dye-Binding, Albumin, 1); GIF (Diluent, Blood Cell, 1).
Next steps
- See all 8 Laboratory Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CHJ, Laboratory Products, 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.