Company ยท US
Biocircuits Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 1998. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 2 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| KHO | Fluorometer, For Clinical Use | 1 |
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 13, 1998 | K981634 | BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS Biocircuits Corp. | LTJ |
| Apr 3, 1998 | K980819 | BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS Biocircuits Corp. | CEC |
| Dec 5, 1996 | K963770 | BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS Biocircuits Corp. | JJY |
| Nov 18, 1996 | K961566 | BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS Biocircuits Corp. | JLW |
| Aug 21, 1996 | K961792 | BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS Biocircuits Corp. | DHA |
| Nov 22, 1995 | K952719 | BIOCIRCUITS IOS (IN-OFFICE SYSTEM) Biocircuits Corp. | KHO |
| Nov 20, 1995 | K953837 | BIOCIRCUITS IOS T4 TEST CARTRIDGE Biocircuits Corp. | KLI |
| Nov 20, 1995 | K952751 | BIOCIRCUITS IOS T4/TU TEST CARTRIDGES Biocircuits Corp. | KLI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||