Company ยท US
Biotecx Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 1999. 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 |
|---|---|---|
| CDP | Radioimmunoassay, Total Triiodothyronine | 2 |
| CGR | Radioimmunoassay, Cortisol | 2 |
| JLS | Radioimmunoassay, Progesterone | 2 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 2 |
| CGI | Radioimmunoassay, Estriol | 1 |
| CHP | Radioimmunoassay, Estradiol | 1 |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 1 |
| JMX | Ninhydrin, Nitrogen (Amino-Nitrogen) | 1 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 |
| KQN | Radioassay, Angiotensin Converting Enzyme | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 3, 1999 | K982298 | OPTICOAT T4 EIA KIT Biotecx Laboratories, Inc. | KLI |
| Dec 22, 1998 | K981824 | OPTICOAT T3 EIA KIT Biotecx Laboratories, Inc. | CDP |
| Oct 19, 1989 | K895407 | CORTISOL CLASP-BEAD EIA KIT Biotecx Laboratories, Inc. | CGR |
| Aug 11, 1989 | K893620 | T3 CLASP-BEAD EIA KIT Biotecx Laboratories, Inc. | CDP |
| May 22, 1989 | K892853 | T4 CLASP-BEAD EIA KIT Biotecx Laboratories, Inc. | KLI |
| Oct 31, 1988 | K883765 | TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE Biotecx Laboratories, Inc. | KHQ |
| Apr 13, 1987 | K871211 | PROGESTERONE CLASP RADIOIMMUNOASSAY KIT Biotecx Laboratories, Inc. | JLS |
| Sep 25, 1986 | K863188 | HPL RIA KIT Biotecx Laboratories, Inc. | JMX |
| Mar 17, 1986 | K854876 | ALDOSTERONE DIRECT RIA KIT Biotecx Laboratories, Inc. | KQN |
| Jun 6, 1985 | K851540 | ESTRADIOL DIRECT RIA KIT Biotecx Laboratories, Inc. | CHP |
| Feb 1, 1985 | K844767 | RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO Biotecx Laboratories, Inc. | CGI |
| Sep 14, 1984 | K842957 | CORITSOL PREMIX RIA KIT Biotecx Laboratories, Inc. | CGR |
| Aug 7, 1984 | K842555 | DHEA-S DIRECT RIA KIT Biotecx Laboratories, Inc. | JKC |
| May 2, 1984 | K841333 | PROGESTERONE DIRECT RIA KIT-RADIOIMM Biotecx Laboratories, Inc. | JLS |
| Jun 30, 1978 | K780761 | ELECTRO-PLETHYSMOGRAPH Biotecx Laboratories, Inc. | JOM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||