Company ยท US
Biosan Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 1986. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 |
| KEA | Resins, Ion-Exchange | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 |
| DHX | System, Test, Carcinoembryonic Antigen | 1 |
| HLX | Photostimulator, Ac-Powered | 1 |
| HOM | Screen, Tangent, Ac-Powered (Campimeter) | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| KLB | Radioimmunoassay, Tobramycin | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 15, 1986 | K860642 | PHOTRON VISUAL FIELD ANALYZER Biosan Laboratories, Inc. | HOM |
| Nov 1, 1985 | K853812 | PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) Biosan Laboratories, Inc. | HLX |
| Mar 23, 1984 | K832763 | TOBRAMYCIN REAGENT Biosan Laboratories, Inc. | KLB |
| Feb 4, 1984 | K833193 | RADIOIMMUNOASSAY, THYROID STIMU. HORMONE Biosan Laboratories, Inc. | JLW |
| Jan 24, 1984 | K834023 | BIO-SCIENCE LABORATORIES T4 REAGENT Biosan Laboratories, Inc. | CDX |
| Jan 3, 1984 | K833318 | NORMAL GOAT SERUM Biosan Laboratories, Inc. | DHX |
| Dec 8, 1983 | K833320 | AMBERLITE CG50 RESIN, 100-200 MESH Biosan Laboratories, Inc. | KEA |
| Dec 8, 1983 | K833192 | NORMAL URINE CONTROL Biosan Laboratories, Inc. | JJY |
| Dec 8, 1983 | K833191 | ABNORMAL URINE CONTROL Biosan Laboratories, Inc. | JJY |
| Nov 3, 1983 | K833319 | BIO-REX 70 RESIN 100-200 MESH PH6.2 Biosan Laboratories, Inc. | KEA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||