Techhnilab Instruments, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Techhnilab Instruments, Inc.” (first 1977, latest 1981), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 18 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 |
|---|---|---|---|
| GLE | Mixer, Blood Tube | 1 | 1 |
| ILC | Utensil, Eating | 1 | 1 |
| IMC | Bath, Paraffin | 1 | 1 |
| JRQ | Shaker/Stirrer | 1 | 1 |
| LTB | Cyclosporine Radioimmunoassay | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Techhnilab Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K813523 | ELECTRIC SELF STERILIZATION INOCUL. LOOP | LTB | 1981-12-31 | 15 |
| K780543 | THERMAJUST CIRCU-TEMP | JRQ | 1978-05-26 | 53 |
| K780544 | DISC-PAK ROTATOR | GLE | 1978-04-24 | 21 |
| K771434 | MULTI-CAVITY EQUILIBRIUM CELL | — | 1977-08-22 | 21 |
| K770170 | MADDATHERM PARAFFIN BATH | IMC | 1977-01-28 | 3 |
| K770169 | BEESON AUTOMADDAK FEEDER | ILC | 1977-01-28 | 3 |
Recalls
openFDA lists no recalls under a recalling firm named Techhnilab Instruments, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Techhnilab Instruments, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Techhnilab Instruments, Inc.” (first 1977, latest 1981), across 6 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 Techhnilab Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Techhnilab Instruments, Inc. is 18 days.
Which FDA product codes appear under Techhnilab Instruments, Inc.?
The most frequent FDA product codes under this applicant name are GLE (Mixer, Blood Tube, 1); ILC (Utensil, Eating, 1); IMC (Bath, Paraffin, 1).
Next steps
- See all 6 Techhnilab Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GLE, Techhnilab Instruments, 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.