Immuchem Covalent Coat Binding
FDA 510(k) K791662 · Immuchem Corp.
510(k) numberK791662
Submission
- Device name
- Immuchem Covalent Coat Binding
- Applicant
- Immuchem Corp.
Mchenry, IL, US - Received
- August 21, 1979
- Decision date
- September 27, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KHQ – Radioassay, Triiodothyronine Uptake
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1715
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K981375 | Ace T Uptake Reagent Tu CalibratorsKHQ · Traditional | Schiapparelli Biosystems, Inc. | 06/10/1998SE |
| K980088 | T-Uptake Microplate EiaKHQ · Traditional | Monobind | 02/04/1998SE |
| K970539 | Chiron Diagnostics ACS:180TU PKHQ · Traditional | Chiron Diagnostics Corp. | 03/24/1997SE |
| K964308 | Vitros Immunodiagnostics Products T3 Uptake Reagent Pack (GEM.1025) and T3 Uptake…KHQ · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 11/27/1996SE |
| K961488 | Elecsys T-Uptake AssayKHQ · Traditional | Boehringer Mannheim Corp. | 06/12/1996SE |
| K954807 | Cedia T Uptake AssayKHQ · Traditional | Boehringer Mannheim Corp. | 12/21/1995SE |
| K951586 | T-Uptake Eia TestKHQ · Traditional | Diagnostic Reagents, Inc. | 05/15/1995SE |
| K933414 | Stratus(R) Thyroid Uptake Fluor Enzyme ImmunoassayKHQ · Traditional | Baxter Diagnostics, Inc. | 11/22/1994SE |
| K934312 | Axsym(Tm) T-UptakeKHQ · Traditional | Abbott Laboratories | 06/21/1994SE |
| K935816 | Vidas T UptakeKHQ · Traditional | Biomerieux Vitek, Inc. | 03/22/1994SE |
More from Biomerieux Vitek, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883726 | Thyroid Stimulating Hormone (HTSH) Irma NeonatalJLW · Traditional | 12/15/1988SE |
| K871317 | Follicle Stimulating Hormone (HFSH)CGJ · Traditional | 05/20/1987SE |
| K871542 | Hprolactin KitCFT · Traditional | 05/14/1987SE |
| K865071 | Thyroid Stimulating Hormone (TSH Irma) Ria KitJLW · Traditional | 03/13/1987SE |
| K864144 | Luteinizing Hormone (Lh-Irma) Ria KitCEP · Traditional | 11/24/1986SE |
| K860559 | Androstenedione 125I Kit by RiaCIZ · Traditional | 03/14/1986SE |
| K854094 | Immuchem Covalent Coat a Solid Phase RadioimmunoasJLS · Traditional | 02/28/1986SE |
| K830962 | Immuchem Covalent-Coat Ria KitDPO · Traditional | 05/04/1983SE |
| K822509 | Covalent Coat Ria KitCFP · Traditional | 09/28/1982SE |
| K822140 | Immuchem Covalent-CoatJKC · Traditional | 08/05/1982SE |
Questions and answers
When was Immuchem Covalent Coat Binding cleared by the FDA?
Immuchem Covalent Coat Binding (K791662) received a 510(k) decision of Substantially Equivalent on September 27, 1979, 37 days after the submission was received.
What is the product code of K791662?
The FDA product code is KHQ – Radioassay, Triiodothyronine Uptake, a Class II (moderate risk) device regulated under 21 CFR 862.1715.