Labsystems, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Labsystems, Inc.” (first 1984, latest 1993), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 43 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 |
|---|---|---|---|
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 5 | 5 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 5 | 5 |
| GQI | Antiserum, Cf, Cytomegalovirus | 2 | 2 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 2 | 2 |
| ITI | Wheelchair, Powered | 1 | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | 1 |
| KHE | Reagent, Occult Blood | 1 | 1 |
Review panels
- Microbiology (12)
- Clinical Chemistry (3)
- Hematology (1)
- Physical Medicine (1)
Most recent Labsystems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K923365 | TILT/REDUCED SHEAR SEMI-RECLINE SEATING SYSTEM | ITI | 1993-03-24 | 259 |
| K896474 | RESUBMITTED FECATWIN SENSITIVE - FECA-EIA | KHE | 1990-01-25 | 73 |
| K890154 | MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA | LGD | 1989-02-07 | 26 |
| K890091 | MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KIT | LFX | 1989-02-03 | 29 |
| K881243 | RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201 | LFX | 1988-04-04 | 14 |
| K873780 | MODIFICATION RUBELLA IGM EIA TEST KIT | LFX | 1987-10-15 | 35 |
| K873583 | AUTO-EIA | JJQ | 1987-09-22 | 19 |
| K872252 | MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT | LGD | 1987-07-01 | 20 |
| K862705 | CYTOMEGALOVIRUS IGG EIA TEST KIT | GQI | 1986-10-01 | 77 |
| K862431 | RUBELLA IGM EIA TEST KIT | LFX | 1986-08-08 | 43 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Labsystems, 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 Labsystems, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Labsystems, Inc.” (first 1984, latest 1993), across 7 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 Labsystems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Labsystems, Inc. is 43 days.
Which FDA product codes appear under Labsystems, Inc.?
The most frequent FDA product codes under this applicant name are LFX (Enzyme Linked Immunoabsorbent Assay, Rubella, 5); LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii, 5); GQI (Antiserum, Cf, Cytomegalovirus, 2).
Next steps
- See all 17 Labsystems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LFX, Labsystems, 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.