Fiagen T3 Uptake Catalogue #101-402
FDA 510(k) K895186 · Cyberfluor, Inc.
510(k) numberK895186
Submission
- Device name
- Fiagen T3 Uptake Catalogue #101-402
- Applicant
- Cyberfluor, Inc.
Ontario M5t 1x4, CA - Received
- August 11, 1989
- Decision date
- November 8, 1989
- 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
Other 510(k)s with product code KHQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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.
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|---|---|---|
| K923410 | Fiagen ProgesteroneJLS · Traditional | 12/03/1992SE |
| K905656 | Flagen Triiodothyronine (T3) AssayCDP · Traditional | 01/23/1991SE |
| K904539 | Flagen TM Free T4CEC · Traditional | 11/30/1990SE |
| K900621 | Fiagen(Tm) Hlh.SCEP · Traditional | 03/01/1990SE |
| K895396 | Cyberfluor Fiagen TSHJLW · Traditional | 10/31/1989SE |
| K884708 | Fiagen HFSH Time-Resolved Fluoroimmunoassay KitCGJ · Traditional | 01/17/1989SE |
| K884707 | Fiagen Digoxin Time-Resolved Fluoroimmunoassay KitLCS · Traditional | 01/17/1989SE |
| K884201 | Fiagen TBG Time-Resolved Fluoroimmunoassay KitCEE · Traditional | 12/14/1988SE |
| K883182 | Fiagen Rubella IggLFX · Traditional | 10/31/1988SE |
| K882823 | Fiagen HGH Fluoroimmunoassay KitCFL · Traditional | 08/30/1988SE |
Questions and answers
When was Fiagen T3 Uptake Catalogue #101-402 cleared by the FDA?
Fiagen T3 Uptake Catalogue #101-402 (K895186) received a 510(k) decision of Substantially Equivalent on November 8, 1989, 89 days after the submission was received.
What is the product code of K895186?
The FDA product code is KHQ – Radioassay, Triiodothyronine Uptake, a Class II (moderate risk) device regulated under 21 CFR 862.1715.