Company ยท US
Cirrus Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 1992. 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 |
|---|---|---|
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CEE | Radioimmunoassay, Thyroxine-Binding Globulin | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 |
| DPO | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep. | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 9, 1992 | K921704 | IMMULITE(R) FSH Cirrus Diagnostics, Inc. | CGJ |
| Mar 11, 1992 | K920411 | IMMULITE HLH Cirrus Diagnostics, Inc. | CEP |
| Nov 22, 1991 | K914833 | IMMULITE DIGOXIN Cirrus Diagnostics, Inc. | DPO |
| Jun 20, 1991 | K911796 | IMMULITE(TM) HCG Cirrus Diagnostics, Inc. | DHA |
| Apr 29, 1991 | K910677 | IMMULITE(TM) T-UPTAKE Cirrus Diagnostics, Inc. | CEE |
| Apr 16, 1991 | K910261 | IMMULITE(TM) TOTAL T4 Cirrus Diagnostics, Inc. | KLI |
| Mar 6, 1991 | K905648 | CRP LIPID REAGENT TEST PACK Cirrus Diagnostics, Inc. | CHH |
| Feb 1, 1991 | K905214 | IMMULITE (TM) TOTAL T3 Cirrus Diagnostics, Inc. | CDP |
| Jan 31, 1991 | K905769 | IMMULITE HS-TSH Cirrus Diagnostics, Inc. | JLW |
| Jan 11, 1991 | K905215 | IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER Cirrus Diagnostics, Inc. | JJQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||