Autopak 12 T3 Ria Test Delivery System
FDA 510(k) K791375 · Micromedic Systems
510(k) numberK791375
Submission
- Device name
- Autopak 12 T3 Ria Test Delivery System
- Applicant
- Micromedic Systems
- Received
- July 24, 1979
- Decision date
- October 11, 1979
- 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 |
|---|---|---|
| K923643 | MedicoolILO · Traditional | 03/31/1993SE |
| K872309 | Micromedic Combostat Lh/Fsh KitCGJ · Traditional | 07/31/1987SE |
| K871505 | Autopak Neonatal TSH Monoclonal Irma KitJLW · Traditional | 05/26/1987SE |
| K871008 | Micromedic Neonatal T4 KitCDX · Traditional | 05/26/1987SE |
| K870904 | Micromedic Neonatal TSH Monoclonal Irma KitJLW · Traditional | 05/26/1987SE |
| K870245 | Autopak TSH Monoclonal Irma KitJLW · Traditional | 04/01/1987SE |
| K862206 | Taurus (TM) Automatic Liquid Scintillation CounterJJJ · Traditional | 08/04/1986SE |
| K860813 | Micromedic HTSH Monoclonal Irma KitJLW · Traditional | 07/14/1986SE |
| K861262 | MMS T3 UptakeKHQ · Traditional | 05/23/1986SE |
| K861320 | MMS T4 Ria KitCDX · Traditional | 04/24/1986SE |
Questions and answers
When was Autopak 12 T3 Ria Test Delivery System cleared by the FDA?
Autopak 12 T3 Ria Test Delivery System (K791375) received a 510(k) decision of Substantially Equivalent on October 11, 1979, 79 days after the submission was received.
What is the product code of K791375?
The FDA product code is CDP – Radioimmunoassay, Total Triiodothyronine, a Class II (moderate risk) device regulated under 21 CFR 862.1710.