Ria, Insulin, Double Antibody
FDA 510(k) K790630 · Endocrine-Metabolic Center
510(k) numberK790630
Submission
- Device name
- Ria, Insulin, Double Antibody
- Applicant
- Endocrine-Metabolic Center
Mchenry, IL, US - Received
- March 27, 1979
- Decision date
- July 24, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CFP – Radioimmunoassay, Immunoreactive Insulin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1405
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CFP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K963911 | Alpco/Mercodia Insulin ElisaCFP · Traditional | American Laboratory Products Co., Ltd. | 11/01/1996SE |
| K953084 | Access Ultrasensitive Insulin AssayCFP · Traditional | Bio-Rad Laboratories, Inc. | 09/25/1995SE |
| K920109 | Imx InsulinCFP · Traditional | Abbott Laboratories | 05/07/1992SE |
| K914820 | DSL Insulin Ria (DSL 1600)CFP · Traditional | Diagnostic Systems Laboratories, Inc. | 01/09/1992SE |
| K903628 | Aia-Pack IriCFP · Traditional | Tosoh Corp. | 09/07/1990SE |
| K901135 | Enzymun Test(R) InsulinCFP · Traditional | Boehringer Mannheim Corp. | 04/03/1990SE |
| K896572 | Rep(Tm) Spe PLUS-30 ProceduresCFP · Traditional | Helena Laboratories | 01/11/1990SE |
| K890837 | Ria-Gnost InsulinCFP · Traditional | Cambridge Medical Technology | 04/26/1989SE |
| K851071 | Pharmacia Insulin RiaCFP · Traditional | Pharmacia, Inc. | 04/12/1985SE |
| K841573 | Insulin Radioimmunoassay KitCFP · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 05/16/1984SE |
More from Sorin Biomedica, Fiat, USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K821131 | Radioimmunoassay Parathyroid Hormone MidCEW · Traditional | 06/02/1982SE |
| K811993 | Radioimmunoassay, Follicle StimulatingCGJ · Traditional | 08/03/1981SE |
| K811994 | Radioimmunoassay Luteinizing HormoneCEP · Traditional | 07/27/1981SE |
| K810948 | Radioimmunoassay Thyroid Stim. Horm. KitJLW · Traditional | 04/17/1981SE |
| K810351 | Radioimmunoassay, Total TriiodothronieCDP · Traditional | 02/23/1981SE |
| K800188 | EMC-M-180, T3 Uptake - 100 TubesKHQ · Traditional | 02/13/1980SE |
| K800187 | EMC-M-175, Thyroxine - 100 TubesCDX · Traditional | 02/13/1980SE |
| K790602 | Ria, DIGNXIN-125-IDPB · Traditional | 07/30/1979SE |
Questions and answers
When was Ria, Insulin, Double Antibody cleared by the FDA?
Ria, Insulin, Double Antibody (K790630) received a 510(k) decision of Substantially Equivalent on July 24, 1979, 119 days after the submission was received.
What is the product code of K790630?
The FDA product code is CFP – Radioimmunoassay, Immunoreactive Insulin, a Class I (low risk) device regulated under 21 CFR 862.1405.