Immulite (TM) Total T3
FDA 510(k) K905214 · Cirrus Diagnostics, Inc.
510(k) numberK905214
Submission
- Device name
- Immulite (TM) Total T3
- Applicant
- Cirrus Diagnostics, Inc.
Chester, NJ, US - Received
- November 20, 1990
- Decision date
- February 1, 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
Other 510(k)s with product code CDP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K921704 | Immulite(R) FSHCGJ · Traditional | 06/09/1992SE |
| K920411 | Immulite HLHCEP · Traditional | 03/11/1992SE |
| K914833 | Immulite DigoxinDPO · Traditional | 11/22/1991SE |
| K911796 | Immulite(Tm) HCGDHA · Traditional | 06/20/1991SE |
| K910677 | Immulite(Tm) T-UptakeCEE · Traditional | 04/29/1991SE |
| K910261 | Immulite(Tm) Total T4KLI · Traditional | 04/16/1991SE |
| K905648 | CRP Lipid Reagent Test PackCHH · Traditional | 03/06/1991SE |
| K905769 | Immulite Hs-TshJLW · Traditional | 01/31/1991SE |
| K905215 | Immulite (TM) Automated Immunoassay AnalyzerJJQ · Traditional | 01/11/1991SE |
Questions and answers
When was Immulite (TM) Total T3 cleared by the FDA?
Immulite (TM) Total T3 (K905214) received a 510(k) decision of Substantially Equivalent on February 1, 1991, 73 days after the submission was received.
What is the product code of K905214?
The FDA product code is CDP – Radioimmunoassay, Total Triiodothyronine, a Class II (moderate risk) device regulated under 21 CFR 862.1710.