Slt Labinstruments, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Slt Labinstruments, Inc.” (first 1985, latest 1992), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 70 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 6 | 6 |
| JTC | Device, Microtiter Diluting/Dispensing | 2 | 2 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 1 | 1 |
Review panels
- Clinical Chemistry (6)
- Microbiology (3)
Most recent Slt Labinstruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K915690 | SLT 340 ATTC | JJQ | 1992-04-22 | 121 |
| K915689 | SLT SPECTRA | JJQ | 1992-04-22 | 121 |
| K902776 | SPECTROPHOTOMETER (MICROASSAY PLATE READERS) | JJQ | 1990-07-31 | 36 |
| K881797 | EASY WASHER II MICROPLATE WASHER | JJQ | 1988-06-15 | 49 |
| K873678 | SPECTROPHOTOMETER (MICROASSAY PLATE READERS) | JJQ | 1987-09-29 | 15 |
| K844894 | PHOTOMETER VARIOUS ONE FOR MICROTITERPLATES | JJQ | 1985-06-25 | 190 |
| K844893 | SLT 223 DISPENSER FOR MICROTITERPLATES | JTC | 1985-02-25 | 70 |
| K844892 | SLT 220 WASHER FOR MICROITITERPLATES | JTZ | 1985-02-25 | 70 |
| K844891 | SLT 225 WASHER/DISPENSER FOR MICRO TITERPLATES | JTC | 1985-02-25 | 70 |
Recalls
openFDA lists no recalls under a recalling firm named Slt Labinstruments, 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 Slt Labinstruments, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Slt Labinstruments, Inc.” (first 1985, latest 1992), across 3 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 Slt Labinstruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Slt Labinstruments, Inc. is 70 days.
Which FDA product codes appear under Slt Labinstruments, Inc.?
The most frequent FDA product codes under this applicant name are JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use, 6); JTC (Device, Microtiter Diluting/Dispensing, 2); JTZ (Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth, 1).
Next steps
- See all 9 Slt Labinstruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJQ, Slt Labinstruments, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.