Bioclinical Systems, Inc.
St.Louis, MO, US
Bioclinical Systems, Inc. appears in FDA device records in St.Louis, MO. FDA records list 13 510(k) clearances between and , no 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
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Bioclinical Systems, Inc. between 1985 and 1995. The busiest year on record is 1986, with 5. The most recent is 1995, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 3 |
| 1986 | 5 |
| 1987 | 1 |
| 1994 | 2 |
| 1995 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K950196 | CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA | JTY | Substantially Equivalent | |
| K945911 | CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS | JTZ | Substantially Equivalent | |
| K933122 | MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR | JTY | Substantially Equivalent | |
| K933121 | MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR | JTY | Substantially Equivalent | |
| K873086 | ROUND 1 | JXA | Substantially Equivalent | |
| K860334 | VISI-CHECK HLH TEST MONOCLONAL | CEP | Substantially Equivalent | |
| K860333 | MICRO-ELISA HLH TEST KIT MONOCLONAL | CEP | Substantially Equivalent | |
| K855227 | MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL | KLS | Substantially Equivalent | |
| K854059 | MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO | JHI | Substantially Equivalent | |
| K854379 | MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT | JLW | Substantially Equivalent | |
| K850257 | BCS GLUCOSE COLORIMETRIC TEST | CGA | Substantially Equivalent | |
| K850079 | NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG | LCX | Substantially Equivalent | |
| K850258 | BCS POTASSIUM TURBIDIMETRIC TEST | CEJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JTZCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
- JTYCulture Media, For Isolation Of Pathogenic Neisseria
- KLSEnzyme Immunoassay, Theophylline
- CGAGlucose Oxidase, Glucose
- JXAKit, Screening, Urine
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- CEPRadioimmunoassay, Luteinizing Hormone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CEJTetraphenyl Borate, Colorimetry, Potassium
- JHIVisual, Pregnancy Hcg, Prescription Use
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