Company ยท US
Immuno Assay Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1984. 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 |
|---|---|---|
| CDX | Radioimmunoassay, Total Thyroxine | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CEF | Electrophoretic, Protein Fractionation | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 |
| DNL | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep. | 1 |
| DPO | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep. | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| JQG | Radiometric, Fe59, Iron Binding Capacity | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 17, 1984 | K833842 | RIA COAT DIGOXIN Immuno Assay Corp. | DPO |
| Jan 4, 1984 | K833745 | RIACOAT T-4 Immuno Assay Corp. | CDX |
| Jan 28, 1982 | K820089 | TSH (RIA) KIT Immuno Assay Corp. | JLW |
| Jan 28, 1982 | K820074 | CORTISOL (RIA) KIT Immuno Assay Corp. | CGR |
| Jul 27, 1981 | K811954 | COMBO-FER IRON DIAGNOSTIC Immuno Assay Corp. | JQG |
| Jul 10, 1981 | K811725 | TBG DIAGNOSTIC KIT Immuno Assay Corp. | CEF |
| May 29, 1981 | K811213 | T3 (RIA) KIT Immuno Assay Corp. | CDP |
| May 21, 1981 | K811212 | DIGOXIN (RIA) KIT Immuno Assay Corp. | DNL |
| Apr 8, 1981 | K810857 | T3 UPTAKE KIT Immuno Assay Corp. | KHQ |
| Apr 7, 1981 | K810811 | T4 RIA KIT Immuno Assay Corp. | CDX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||