Company ยท US
Bioclinical Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 1995. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 3 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 2 |
| CEJ | Tetraphenyl Borate, Colorimetry, Potassium | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 1 |
| JXA | Kit, Screening, Urine | 1 |
| KLS | Enzyme Immunoassay, Theophylline | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 30, 1995 | K950196 | CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA Bioclinical Systems, Inc. | JTY |
| Apr 4, 1995 | K945911 | CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS Bioclinical Systems, Inc. | JTZ |
| Feb 9, 1994 | K933122 | MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR Bioclinical Systems, Inc. | JTY |
| Feb 3, 1994 | K933121 | MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR Bioclinical Systems, Inc. | JTY |
| Aug 24, 1987 | K873086 | ROUND 1 Bioclinical Systems, Inc. | JXA |
| Apr 21, 1986 | K860334 | VISI-CHECK HLH TEST MONOCLONAL Bioclinical Systems, Inc. | CEP |
| Apr 21, 1986 | K860333 | MICRO-ELISA HLH TEST KIT MONOCLONAL Bioclinical Systems, Inc. | CEP |
| Apr 11, 1986 | K855227 | MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL Bioclinical Systems, Inc. | KLS |
| Jan 13, 1986 | K854059 | MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO Bioclinical Systems, Inc. | JHI |
| Jan 7, 1986 | K854379 | MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT Bioclinical Systems, Inc. | JLW |
| Mar 5, 1985 | K850257 | BCS GLUCOSE COLORIMETRIC TEST Bioclinical Systems, Inc. | CGA |
| Mar 5, 1985 | K850079 | NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG Bioclinical Systems, Inc. | LCX |
| Feb 7, 1985 | K850258 | BCS POTASSIUM TURBIDIMETRIC TEST Bioclinical Systems, Inc. | CEJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||