Company ยท US
Wien Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1991. 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 |
|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 2 |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 2 |
| JLX | Radioimmunoassay, 17-Hydroxyprogesterone | 2 |
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | 2 |
| CGI | Radioimmunoassay, Estriol | 1 |
| CIY | Radioimmunoassay, Androsterone | 1 |
| CIZ | Radioimmunoassay, Androstenedione | 1 |
| DNL | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep. | 1 |
| DPB | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep. | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 12, 1991 | K912850 | SHBG Wien Laboratories, Inc. | CDZ |
| Feb 4, 1984 | K834246 | PROGESTERONE TEST SET 125I 17-OH Wien Laboratories, Inc. | JLX |
| Sep 12, 1983 | K832452 | ANDROSTENEDIONE TEST SET 125I Wien Laboratories, Inc. | CIZ |
| Nov 29, 1982 | K823200 | 125 I-DEHYDROEPIANDROSTERONE SULFATE Wien Laboratories, Inc. | JKC |
| Jun 14, 1982 | K821653 | PROTRIPTYLINE TRI-CY TEST SET Wien Laboratories, Inc. | LFG |
| Jun 14, 1982 | K821652 | DOXEPIN TRI-CY TEST SET Wien Laboratories, Inc. | LFG |
| Dec 11, 1980 | K802728 | 125I-TESTOSTERONE TEST SET Wien Laboratories, Inc. | CDZ |
| Oct 30, 1979 | K792041 | DHEA-SULFATE TEST SET Wien Laboratories, Inc. | JKC |
| Jan 3, 1979 | K781834 | TEST SET, 125 I-DIGOXIN Wien Laboratories, Inc. | DNL |
| Oct 17, 1978 | K781599 | I-ESTRIOL TEST SET Wien Laboratories, Inc. | CGI |
| Dec 22, 1977 | K772306 | 125I DIGOXIN TEST SET Wien Laboratories, Inc. | DPB |
| Nov 2, 1977 | K771793 | DHEA TEST SET Wien Laboratories, Inc. | CIY |
| Oct 21, 1977 | K771729 | 17-HYDROXYPROGESTERONE TEST SET Wien Laboratories, Inc. | JLX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||