Gammacoat (125) Insulin Radioimmunoassay
FDA 510(k) K812227 · Clinical Assays, Inc.
510(k) numberK812227
Submission
- Device name
- Gammacoat (125) Insulin Radioimmunoassay
- Applicant
- Clinical Assays, Inc.
Mchenry, IL, US - Received
- August 10, 1981
- Decision date
- September 24, 1981
- 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 |
|---|---|---|
| K832712 | Folate Radioassay Kit CA-1562-125CGN · Traditional | 10/04/1983SE |
| K832711 | Vitamin B12 Folate CA-1515-125CDD · Traditional | 10/04/1983SE |
| K832710 | Vitamin B12 Radioassay Kit CA-1534CDD · Traditional | 10/04/1983SE |
| K823476 | Gammadab LH Radio-Kit #CA-1508CEP · Traditional | 12/28/1982SE |
| K823313 | In Vitro Gammacoat B-Hcg Radio. TestJHI · Traditional | 12/22/1982SE |
| K821611 | Gammadab [125] FSH Radioimmunay KitCGJ · Traditional | 06/24/1982SE |
| K821092 | GAMMADAB[125]EGE Radioimmunoassay ItDGC · Traditional | 06/22/1982SE |
| K810722 | Gastrin Radioimmunoassay TestCGC · Traditional | 05/27/1981SE |
| K810967 | In-Vitro TBG Radioimmunoassay TestCEE · Traditional | 04/23/1981SE |
| K801667 | Gamma COAT(125 I) Rubella AntibodyGOL · Traditional | 10/23/1980SE |
Questions and answers
When was Gammacoat (125) Insulin Radioimmunoassay cleared by the FDA?
Gammacoat (125) Insulin Radioimmunoassay (K812227) received a 510(k) decision of Substantially Equivalent on September 24, 1981, 45 days after the submission was received.
What is the product code of K812227?
The FDA product code is CFP – Radioimmunoassay, Immunoreactive Insulin, a Class I (low risk) device regulated under 21 CFR 862.1405.