Flagen Triiodothyronine (T3) Assay
FDA 510(k) K905656 · Cyberfluor, Inc.
510(k) numberK905656
Submission
- Device name
- Flagen Triiodothyronine (T3) Assay
- Applicant
- Cyberfluor, Inc.
Ontario M5t 1x4, CA - Received
- December 17, 1990
- Decision date
- January 23, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CDP – Radioimmunoassay, Total Triiodothyronine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1710
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K001607 | Reprobead T3 Enzyme Immunoassay Reagent Kit (Catalog# 104)CDP · Traditional | Repromedix Corp. | 10/05/2000SE |
| K991692 | Chiron Diagnostics Acs: 180 FT3CDP · Traditional | Chiron Diagnostics Corp. | 06/18/1999SE |
| K991311 | Total T3 Enzyme Immunoassay Test Kit, Model BC-1005CDP · Traditional | Biocheck, Inc. | 06/02/1999SE |
| K991252 | Aia-Pack FT3 AssayCDP · Traditional | Tosoh Medics, Inc. | 05/11/1999SE |
| K981824 | Opticoat T3 Eia KitCDP · Traditional | Biotecx Laboratories, Inc. | 12/22/1998SE |
| K983439 | Abbott Architect Free T3CDP · Traditional | Abbott Laboratories | 11/20/1998SE |
| K983434 | Abbott Architect Total T3CDP · Traditional | Abbott Laboratories | 11/20/1998SE |
| K974027 | Auraflex FT3 150 Test Pack, Auraflex FT3 Calibrator PackCDP · Traditional | Alfa Biotech (Uk) , Ltd. | 02/02/1998SE |
| K974634 | Immulite Free T3CDP · Traditional | Diagnostic Products Corp. | 01/02/1998SE |
| K973966 | Access Total T3 Reagents on the Access Immunoassay AnalyzerCDP · Traditional | Beckman Instruments, Inc. | 10/31/1997SE |
More from Beckman Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K923410 | Fiagen ProgesteroneJLS · Traditional | 12/03/1992SE |
| K904539 | Flagen TM Free T4CEC · Traditional | 11/30/1990SE |
| K900621 | Fiagen(Tm) Hlh.SCEP · Traditional | 03/01/1990SE |
| K895186 | Fiagen T3 Uptake Catalogue #101-402KHQ · Traditional | 11/08/1989SE |
| 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 Flagen Triiodothyronine (T3) Assay cleared by the FDA?
Flagen Triiodothyronine (T3) Assay (K905656) received a 510(k) decision of Substantially Equivalent on January 23, 1991, 37 days after the submission was received.
What is the product code of K905656?
The FDA product code is CDP – Radioimmunoassay, Total Triiodothyronine, a Class II (moderate risk) device regulated under 21 CFR 862.1710.