Company ยท US
Monobind
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2018. Name variants (Inc, Corp, punctuation) are merged.
23510(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 | 3 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 3 |
| CDX | Radioimmunoassay, Total Thyroxine | 2 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 2 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 2 |
| KHQ | Radioassay, Triiodothyronine Uptake | 2 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 2 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 |
| DDC | Thyroglobulin, Antigen, Antiserum, Control | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
| JNL | Immunochemical, Thyroglobulin Autoantibody | 1 |
| LCS | Radioimmunoassay, Digoxin (125-I) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 20, 2018 | K181017 | Free Testosterone AccuBind ELISA Test System Monobind, Inc. | CDZ |
| Apr 4, 2008 | K063437 | ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 Monobind, Inc. | JLW |
| Aug 22, 2003 | K030860 | ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 Monobind | KLI |
| Apr 5, 2002 | K020548 | FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 Monobind | CEC |
| Feb 4, 1998 | K980088 | T-UPTAKE MICROPLATE EIA Monobind | KHQ |
| Sep 2, 1997 | K972720 | FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) Monobind | CGJ |
| Jul 3, 1997 | K971835 | ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA Monobind | DDC |
| Jul 3, 1997 | K971834 | ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA Monobind | JNL |
| Jun 24, 1997 | K971921 | PROLACTIN (PRL) HORMONE MICROPLATE ELISA Monobind | CFT |
| Jun 24, 1997 | K971780 | THYROTROPIN(TSH) ELISA Monobind | JLW |
| Jun 16, 1997 | K971779 | TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA Monobind | CDP |
| Jun 16, 1997 | K971709 | TOTAL THROXINE MICROPLATE EIA(225-300) Monobind | KLI |
| Feb 25, 1993 | K926345 | TRIODOTHYRONINE (TC) COATED TUBE RIA Monobind | CDP |
| Aug 24, 1992 | K922353 | DIGOXIN COATED TUBE RIA Monobind | LCS |
| Jul 7, 1992 | K921935 | THYROXINE (T4) COATED TUBE RIA Monobind | CDX |
| Jan 28, 1986 | K854958 | HCG RIA TEST SYSTEM Monobind | JHI |
| Apr 5, 1983 | K830412 | RADIOIMMUNOASSAY TEST SYSTEM PRL Monobind | CFT |
| Apr 16, 1982 | K820760 | LH RADIOIMMUNOASSAY TEST SYSTEM Monobind | CEP |
| Feb 4, 1982 | K820048 | FSH RADIOIMMUNOASSAY TEST SYSTEM Monobind | CGJ |
| Mar 22, 1978 | K780361 | T3 UPTAKE TEST Monobind | KHQ |
| Aug 4, 1977 | K771222 | TSH RIA TEST SYSTEM Monobind | JLW |
| Aug 4, 1977 | K771221 | T4 RIA TEST SYSTEM Monobind | CDX |
| Aug 4, 1977 | K771220 | T3 RIA TEST SYSTEM Monobind | CDP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||