Company ยท US
Radioassay Systems Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 1986. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CGR | Radioimmunoassay, Cortisol | 2 |
| JLS | Radioimmunoassay, Progesterone | 2 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 |
| CFP | Radioimmunoassay, Immunoreactive Insulin | 1 |
| CGI | Radioimmunoassay, Estriol | 1 |
| CHP | Radioimmunoassay, Estradiol | 1 |
| CIZ | Radioimmunoassay, Androstenedione | 1 |
| CJM | Radioimmunoassay, Aldosterone | 1 |
| CKG | Radioimmunoassay, Acth | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
| JKB | Radioimmunoassay, Compound S (11-Deoxycortisol) | 1 |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 1 |
| JMD | Radioimmunoassay, Total Estrogens, Nonpregnancy | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 25, 1986 | K862204 | RSL (125I) ALDOSTERONE KIT Radioassay Systems Laboratories, Inc. | CJM |
| Sep 27, 1984 | K842960 | ANDROSTENEDIONE BY RIA Radioassay Systems Laboratories, Inc. | CIZ |
| Apr 18, 1984 | K840886 | HYDROXYPROGESTERONE BY RIA 17A Radioassay Systems Laboratories, Inc. | JLS |
| Jul 28, 1983 | K831855 | HATCH KIT Radioassay Systems Laboratories, Inc. | CKG |
| Oct 23, 1980 | K802195 | DEHYDROEPIANDROSTERONE SULFATE KIT RIA Radioassay Systems Laboratories, Inc. | JKC |
| Feb 13, 1980 | K800126 | RSL (125 L) PROGESTERONE KIT Radioassay Systems Laboratories, Inc. | JLS |
| Oct 30, 1979 | K791999 | (125I) TESTOSTERONE KIT Radioassay Systems Laboratories, Inc. | CDZ |
| Sep 27, 1979 | K791835 | CORALENT COAT 125I CORTISOL RADIOIMM. Radioassay Systems Laboratories, Inc. | CGR |
| Sep 27, 1979 | K791740 | SERUM 11-DESOXYCORTISOL I AS TRACER Radioassay Systems Laboratories, Inc. | JKB |
| Sep 27, 1979 | K791728 | RSL'S ASSAY PROCEDURE QUANTITATION Radioassay Systems Laboratories, Inc. | CGI |
| Sep 27, 1979 | K791652 | ESTRADIOL KIT BY RIA Radioassay Systems Laboratories, Inc. | CHP |
| Sep 27, 1979 | K791651 | TOTAL ESTROGENS KIT BY RIA Radioassay Systems Laboratories, Inc. | JMD |
| Nov 22, 1978 | K781730 | RIA, CORTISOL KIT Radioassay Systems Laboratories, Inc. | CGR |
| Oct 11, 1978 | K781487 | EARLY PREGNANCY DETECTION KIT Radioassay Systems Laboratories, Inc. | JHI |
| Jan 6, 1978 | K772281 | RSL INSULIN KIT Radioassay Systems Laboratories, Inc. | CFP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||