Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Flow Laboratories, Inc. — Predicate Candidate Screening
57 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
17 daysmedian FDA review time
118 days90th percentile
57clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K861897 | UNISKAN II | Flow Laboratories, Inc. | 1986-07-01 | 46 | 0 |
| K862066 | TITERTEK MICROPLATE WASHER S-12 | Flow Laboratories, Inc. | 1986-06-05 | 6 | 0 |
| K861824 | GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) | Flow Laboratories, Inc. | 1986-05-20 | 8 | 0 |
| K861823 | GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) | Flow Laboratories, Inc. | 1986-05-20 | 8 | 0 |
| K861791 | PENICILLIN-STREPTOMYCIN-FUNGIZONE | Flow Laboratories, Inc. | 1986-05-20 | 11 | 0 |
| K860762 | GAMMA-FREE HORSE SERUM | Flow Laboratories, Inc. | 1986-03-10 | 10 | 0 |
| K860752 | GOAT SERUM (29-391-54) | Flow Laboratories, Inc. | 1986-03-10 | 10 | 0 |
| K850908 | TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA | Flow Laboratories, Inc. | 1985-03-25 | 20 | 0 |
| K844419 | TITERTEK MULTISKAN MSS/340 | Flow Laboratories, Inc. | 1985-03-21 | 126 | 0 |
| K844418 | TITERTEK MULTISKAN MCC | Flow Laboratories, Inc. | 1985-03-21 | 126 | 0 |
| K844567 | TITERTEK TWINREADER 78-630-00 | Flow Laboratories, Inc. | 1985-03-21 | 118 | 0 |
| K844568 | TITERTEK DULUTER/DISPENSER 78-640-00 | Flow Laboratories, Inc. | 1985-01-30 | 68 | 0 |
| K844500 | TITERTEK MICROPLATE WASHER 120 | Flow Laboratories, Inc. | 1985-01-22 | 63 | 0 |
| K842049 | FLUOROSKAN | Flow Laboratories, Inc. | 1984-12-03 | 195 | 0 |
| K842182 | TITERTEK-ENTEROBAC RAPID AUTOMATED | Flow Laboratories, Inc. | 1984-06-01 | 0 | 0 |
| K834090 | TITERTEK ENTEROBAC* | Flow Laboratories, Inc. | 1984-01-13 | 46 | 0 |
| K822119 | ACCESSORY MEDIA FOR FLOW TITERTEK MIC | Flow Laboratories, Inc. | 1982-08-03 | 15 | 0 |
| K812947 | MONO-POLY RESOLVING MEDIUM | Flow Laboratories, Inc. | 1982-03-11 | 142 | 0 |
| K820308 | ANA-DISC SYSTEM | Flow Laboratories, Inc. | 1982-03-04 | 28 | 0 |
| K813426 | MULTIWASH | Flow Laboratories, Inc. | 1981-12-22 | 15 | 0 |
| K812818 | TITERTEK AUTODROP | Flow Laboratories, Inc. | 1981-10-23 | 16 | 0 |
| K812340 | TITERTEK MICROPLATE INCUBATOR | Flow Laboratories, Inc. | 1981-09-23 | 36 | 0 |
| K802626 | ANAIROBE-TEK | Flow Laboratories, Inc. | 1980-11-12 | 20 | 0 |
| K802303 | VIRAL TRANSPORT MED. (46-995-04) | Flow Laboratories, Inc. | 1980-10-31 | 38 | 0 |
| K801098 | ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES) | Flow Laboratories, Inc. | 1980-09-16 | 130 | 0 |
| K792058 | ENTERIC-TEK | Flow Laboratories, Inc. | 1980-01-11 | 88 | 0 |
| K790422 | MULTISKAN (78-503-00) | Flow Laboratories, Inc. | 1979-04-20 | 51 | 0 |
| K781875 | STAIN KIT FOR CELL CULTURES (30-100-00) | Flow Laboratories, Inc. | 1978-12-20 | 47 | 0 |
| K781874 | MYCOPLASMA ARGININI FITC (30-403-41) | Flow Laboratories, Inc. | 1978-12-20 | 47 | 0 |
| K781390 | MYCOPLASMA HYORHINIS (BTS-7) | Flow Laboratories, Inc. | 1978-09-01 | 22 | 0 |
| K781388 | F.A. MOUNTING MEDIUM | Flow Laboratories, Inc. | 1978-08-21 | 11 | 0 |
| K781391 | PBS FOR FA (46-991-49) | Flow Laboratories, Inc. | 1978-08-21 | 11 | 0 |
| K780277 | INFLUENZA HI PRESERUM A/TEXAS | Flow Laboratories, Inc. | 1978-02-28 | 11 | 0 |
| K780273 | INFLUENZA HI PRESERUM | Flow Laboratories, Inc. | 1978-02-28 | 11 | 0 |
| K780272 | INFLUENZA HA ANTIGEN | Flow Laboratories, Inc. | 1978-02-28 | 11 | 0 |
| K780275 | INFLUENZA HA ANTIGEN A/USSR | Flow Laboratories, Inc. | 1978-02-28 | 11 | 0 |
| K780276 | INFLUENZA HI ANTISERUM A/TEXAS | Flow Laboratories, Inc. | 1978-02-28 | 11 | 0 |
| K780274 | INFLUENZA HI ANTISERUM | Flow Laboratories, Inc. | 1978-02-28 | 11 | 0 |
| K771955 | TRYPSIN 1% | Flow Laboratories, Inc. | 1977-11-22 | 36 | 0 |
| K771956 | HUMAN O BUFFER | Flow Laboratories, Inc. | 1977-10-28 | 11 | 0 |
| K771957 | RUBELLA HEMAGGLUTINATION REAGENT KIT | Flow Laboratories, Inc. | 1977-10-28 | 11 | 0 |
| K770805 | MEASLES-FA LABELLED (8-441 RF) | Flow Laboratories, Inc. | 1977-05-20 | 17 | 0 |
| K770811 | ADENOVIRUS GROUP-FA LABELLED PRESERUM | Flow Laboratories, Inc. | 1977-05-20 | 17 | 0 |
| K770808 | RESP. SYNCYTIAL-FA LABELLED PRESERUM | Flow Laboratories, Inc. | 1977-05-20 | 17 | 0 |
| K770809 | MEASLES-FA LABELED PRESERUM (8-441 RNF) | Flow Laboratories, Inc. | 1977-05-20 | 17 | 0 |
| K770806 | VARICELLA-ZOSTER FA LABELLED (8-321 RF) | Flow Laboratories, Inc. | 1977-05-20 | 17 | 0 |
| K770807 | ADENOVIRUS-GROUP FA LABELLED (8-651 RF) | Flow Laboratories, Inc. | 1977-05-20 | 17 | 0 |
| K770810 | VARICELLA-ZOSTER FA LABELED PRESERUM | Flow Laboratories, Inc. | 1977-05-20 | 17 | 0 |
| K770804 | RESP. SYNCYTIAL-FA LABELLHD (8-301-RF) | Flow Laboratories, Inc. | 1977-05-20 | 17 | 0 |
| K770216 | VIRAL ANTISERA, FLUORESCEIN LABELED | Flow Laboratories, Inc. | 1977-03-01 | 27 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda