Flow Laboratories, Inc.
Mchenry, IL, US
Flow Laboratories, Inc. appears in FDA device records in Mchenry, IL. FDA records list 57 510(k) clearances between and , 2 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 57
- PMA records
- 2
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 57FDA records hold 57 510(k) clearances for Flow Laboratories, Inc. between 1976 and 1986. The busiest year on record is 1977, with 12. The most recent is 1986, with 7.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 7 |
| 1977 | 12 |
| 1978 | 11 |
| 1979 | 1 |
| 1980 | 4 |
| 1981 | 3 |
| 1982 | 3 |
| 1984 | 3 |
| 1985 | 6 |
| 1986 | 7 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K861897 | UNISKAN II | JJQ | Substantially Equivalent | |
| K862066 | TITERTEK MICROPLATE WASHER S-12 | JTC | Substantially Equivalent | |
| K861824 | GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) | JSK | Substantially Equivalent | |
| K861823 | GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) | JSK | Substantially Equivalent | |
| K861791 | PENICILLIN-STREPTOMYCIN-FUNGIZONE | JSK | Substantially Equivalent | |
| K860762 | GAMMA-FREE HORSE SERUM | KIS | Substantially Equivalent | |
| K860752 | GOAT SERUM (29-391-54) | KIS | Substantially Equivalent | |
| K850908 | TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA | JTC | Substantially Equivalent | |
| K844567 | TITERTEK TWINREADER 78-630-00 | JJQ | Substantially Equivalent | |
| K844419 | TITERTEK MULTISKAN MSS/340 | JJQ | Substantially Equivalent | |
| K844418 | TITERTEK MULTISKAN MCC | JJQ | Substantially Equivalent | |
| K844568 | TITERTEK DULUTER/DISPENSER 78-640-00 | JTC | Substantially Equivalent | |
| K844500 | TITERTEK MICROPLATE WASHER 120 | JTC | Substantially Equivalent | |
| K842049 | FLUOROSKAN | JZT | Substantially Equivalent | |
| K842182 | TITERTEK-ENTEROBAC RAPID AUTOMATED | Unknown | ||
| K834090 | TITERTEK ENTEROBAC* | JSS | Substantially Equivalent | |
| K822119 | ACCESSORY MEDIA FOR FLOW TITERTEK MIC | JTZ | Substantially Equivalent | |
| K812947 | MONO-POLY RESOLVING MEDIUM | JCF | Substantially Equivalent | |
| K820308 | ANA-DISC SYSTEM | KZJ | Substantially Equivalent | |
| K813426 | MULTIWASH | JQW | Substantially Equivalent | |
| K812818 | TITERTEK AUTODROP | JTC | Substantially Equivalent | |
| K812340 | TITERTEK MICROPLATE INCUBATOR | JTQ | Substantially Equivalent | |
| K802626 | ANAIROBE-TEK | JSP | Substantially Equivalent | |
| K802303 | VIRAL TRANSPORT MED. (46-995-04) | JSM | Substantially Equivalent | |
| K801098 | ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES) | GOL | Substantially Equivalent | |
| K792058 | ENTERIC-TEK | JSS | Substantially Equivalent | |
| K790422 | MULTISKAN (78-503-00) | JJQ | Substantially Equivalent | |
| K781875 | STAIN KIT FOR CELL CULTURES (30-100-00) | KPB | Substantially Equivalent | |
| K781874 | MYCOPLASMA ARGININI FITC (30-403-41) | KPB | Substantially Equivalent | |
| K781390 | MYCOPLASMA HYORHINIS (BTS-7) | KPB | Substantially Equivalent | |
| K781391 | PBS FOR FA (46-991-49) | KIP | Substantially Equivalent | |
| K781388 | F.A. MOUNTING MEDIUM | KEQ | Substantially Equivalent | |
| K780277 | INFLUENZA HI PRESERUM A/TEXAS | GNS | Substantially Equivalent | |
| K780276 | INFLUENZA HI ANTISERUM A/TEXAS | GNS | Substantially Equivalent | |
| K780275 | INFLUENZA HA ANTIGEN A/USSR | GNT | Substantially Equivalent | |
| K780274 | INFLUENZA HI ANTISERUM | GNS | Substantially Equivalent | |
| K780273 | INFLUENZA HI PRESERUM | GNS | Substantially Equivalent | |
| K780272 | INFLUENZA HA ANTIGEN | GNT | Substantially Equivalent | |
| K771955 | TRYPSIN 1% | IBG | Substantially Equivalent | |
| K771957 | RUBELLA HEMAGGLUTINATION REAGENT KIT | GOK | Substantially Equivalent | |
| K771956 | HUMAN O BUFFER | GOK | Substantially Equivalent | |
| K770811 | ADENOVIRUS GROUP-FA LABELLED PRESERUM | GNY | Substantially Equivalent | |
| K770810 | VARICELLA-ZOSTER FA LABELED PRESERUM | GQX | Substantially Equivalent | |
| K770809 | MEASLES-FA LABELED PRESERUM (8-441 RNF) | GOL | Substantially Equivalent | |
| K770808 | RESP. SYNCYTIAL-FA LABELLED PRESERUM | GQG | Substantially Equivalent | |
| K770807 | ADENOVIRUS-GROUP FA LABELLED (8-651 RF) | GNY | Substantially Equivalent | |
| K770806 | VARICELLA-ZOSTER FA LABELLED (8-321 RF) | GQX | Substantially Equivalent | |
| K770805 | MEASLES-FA LABELLED (8-441 RF) | GOL | Substantially Equivalent | |
| K770804 | RESP. SYNCYTIAL-FA LABELLHD (8-301-RF) | GQG | Substantially Equivalent | |
| K770216 | VIRAL ANTISERA, FLUORESCEIN LABELED | GRA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- GOLAntigen, Ha (Including Ha Control), Rubella
- GNTAntigens, Ha (Including Ha Control), Influenza Virus A, B, C
- GNYAntisera, Fluorescent, Adenovirus 1-33
- GOKAntisera, Hai (Including Hai Control), Rubella
- GNSAntisera, Hai, Influenza Virus A, B, C
- GQXAntiserum, Cf, Varicella-Zoster
- GRAAntiserum, Fluorescent, Mumps Virus
- JTQBath, Incubators/Water, All
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- JTZCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
- JTYCulture Media, For Isolation Of Pathogenic Neisseria
- JSMCulture Media, Non-Propagating Transport
- KZJDevice, Gas Generating
- JTCDevice, Microtiter Diluting/Dispensing
- JZTFluorometer
- KIPFormulations, Balanced Salt Solutions
- JSPKit, Anaerobic Identification
- JSSKit, Identification, Enterobacteriaceae
- JCFLymphocyte Separation Medium
- KPBMedia And Components, Mycoplasma Detection
- KEQMedia, Mounting, Water Soluble
- KISSera, Animal And Human
- JQWStation, Pipetting And Diluting, For Clinical Use
- JSKSupplement, Culture Media
- LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- IBGTrypsin
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain