Company ยท US
Immuchem Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 1988. Name variants (Inc, Corp, punctuation) are merged.
18510(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 |
| JLS | Radioimmunoassay, Progesterone | 2 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 |
| CFP | Radioimmunoassay, Immunoreactive Insulin | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 |
| CHP | Radioimmunoassay, Estradiol | 1 |
| CIZ | Radioimmunoassay, Androstenedione | 1 |
| DPO | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep. | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 15, 1988 | K883726 | THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL Immuchem Corp. | JLW |
| May 20, 1987 | K871317 | FOLLICLE STIMULATING HORMONE (HFSH) Immuchem Corp. | CGJ |
| May 14, 1987 | K871542 | HPROLACTIN KIT Immuchem Corp. | CFT |
| Mar 13, 1987 | K865071 | THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT Immuchem Corp. | JLW |
| Nov 24, 1986 | K864144 | LUTEINIZING HORMONE (LH-IRMA) RIA KIT Immuchem Corp. | CEP |
| Mar 14, 1986 | K860559 | ANDROSTENEDIONE 125I KIT BY RIA Immuchem Corp. | CIZ |
| Feb 28, 1986 | K854094 | IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS Immuchem Corp. | JLS |
| May 4, 1983 | K830962 | IMMUCHEM COVALENT-COAT RIA KIT Immuchem Corp. | DPO |
| Sep 28, 1982 | K822509 | COVALENT COAT RIA KIT Immuchem Corp. | CFP |
| Aug 5, 1982 | K822140 | IMMUCHEM COVALENT-COAT Immuchem Corp. | JKC |
| Mar 4, 1982 | K820329 | ESTRADIOL KIT BY RIA Immuchem Corp. | CHP |
| Dec 22, 1981 | K813484 | PROGESTERONE KIT BY RIA Immuchem Corp. | JLS |
| Jun 18, 1981 | K811536 | DIRECT TESTOSTERONE RIA Immuchem Corp. | CDZ |
| May 29, 1981 | K811398 | EARLY PREGNANCY DETECTION Immuchem Corp. | JHI |
| Aug 27, 1980 | K801666 | TESTOSTERONE KIT Immuchem Corp. | CDZ |
| Oct 1, 1979 | K791663 | IMMUCHEM COVALENT COAT SOLID PHASE ASSAY Immuchem Corp. | CDP |
| Sep 27, 1979 | K791664 | IMMUCHEM COVALENT COAT SOLID PHASE ASSAY Immuchem Corp. | CDX |
| Sep 27, 1979 | K791662 | IMMUCHEM COVALENT COAT BINDING Immuchem Corp. | KHQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||