Flow Laboratories, Inc.: FDA clearances and approvals
Flow Laboratories, Inc. has 57 FDA 510(k) clearances (first 1976, latest 1986), plus 1 PMA decision, across 28 product codes in 5 review panels. Median 510(k) review time: 17 days.
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 | 5 | 5 |
| JTC | Device, Microtiter Diluting/Dispensing | 5 | 5 |
| GNS | Antisera, Hai, Influenza Virus A, B, C | 4 | 4 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 4 | 4 |
| GOL | Antigen, Ha (Including Ha Control), Rubella | 3 | 3 |
| JSK | Supplement, Culture Media | 3 | 3 |
| KPB | Media And Components, Mycoplasma Detection | 3 | 3 |
| GNT | Antigens, Ha (Including Ha Control), Influenza Virus A, B, C | 2 | 2 |
| GNY | Antisera, Fluorescent, Adenovirus 1-33 | 2 | 2 |
| GOK | Antisera, Hai (Including Hai Control), Rubella | 2 | 2 |
Plus 18 more product codes.
Review panels
- Microbiology (38)
- Pathology (8)
- Clinical Chemistry (6)
- Hematology (1)
- Immunology (1)
Most recent Flow Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861897 | UNISKAN II | JJQ | 1986-07-01 | 46 |
| K862066 | TITERTEK MICROPLATE WASHER S-12 | JTC | 1986-06-05 | 6 |
| K861824 | GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) | JSK | 1986-05-20 | 8 |
| K861823 | GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) | JSK | 1986-05-20 | 8 |
| K861791 | PENICILLIN-STREPTOMYCIN-FUNGIZONE | JSK | 1986-05-20 | 11 |
| K860762 | GAMMA-FREE HORSE SERUM | KIS | 1986-03-10 | 10 |
| K860752 | GOAT SERUM (29-391-54) | KIS | 1986-03-10 | 10 |
| K850908 | TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA | JTC | 1985-03-25 | 20 |
| K844567 | TITERTEK TWINREADER 78-630-00 | JJQ | 1985-03-21 | 118 |
| K844419 | TITERTEK MULTISKAN MSS/340 | JJQ | 1985-03-21 | 126 |
47 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| N50538 | PMA | FLOW MIC SYSTEM | 1980-07-15 |
Recalls
openFDA lists no recalls under a recalling firm named Flow Laboratories, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Flow Laboratories, Inc.'s product codes (a text match, not an official crosswalk):
- G0008 — Administration of influenza virus vaccine (via GNS)
- Q2039 — Influenza virus vaccine, not otherwise specified (via GNS)
Frequently asked questions
How many FDA 510(k) clearances does Flow Laboratories, Inc. have?
Flow Laboratories, Inc. has 57 FDA 510(k) clearances (first 1976, latest 1986), plus 1 PMA decision, across 28 product codes in 5 review panels.
How long does FDA take to clear Flow Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Flow Laboratories, Inc.'s cleared 510(k)s is 17 days.
What devices does Flow Laboratories, Inc. make?
Its most frequent FDA product codes are JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use, 5); JTC (Device, Microtiter Diluting/Dispensing, 5); GNS (Antisera, Hai, Influenza Virus A, B, C, 4).
Has Flow Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Flow Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 57 Flow Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJQ, Flow Laboratories, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.