Covalent Coat Ria Kit
FDA 510(k) K822509 · Immuchem Corp.
510(k) numberK822509
Submission
- Device name
- Covalent Coat Ria Kit
- Applicant
- Immuchem Corp.
Mchenry, IL, US - Received
- August 20, 1982
- Decision date
- September 28, 1982
- 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 |
|---|---|---|
| K883726 | Thyroid Stimulating Hormone (HTSH) Irma NeonatalJLW · Traditional | 12/15/1988SE |
| K871317 | Follicle Stimulating Hormone (HFSH)CGJ · Traditional | 05/20/1987SE |
| K871542 | Hprolactin KitCFT · Traditional | 05/14/1987SE |
| K865071 | Thyroid Stimulating Hormone (TSH Irma) Ria KitJLW · Traditional | 03/13/1987SE |
| K864144 | Luteinizing Hormone (Lh-Irma) Ria KitCEP · Traditional | 11/24/1986SE |
| K860559 | Androstenedione 125I Kit by RiaCIZ · Traditional | 03/14/1986SE |
| K854094 | Immuchem Covalent Coat a Solid Phase RadioimmunoasJLS · Traditional | 02/28/1986SE |
| K830962 | Immuchem Covalent-Coat Ria KitDPO · Traditional | 05/04/1983SE |
| K822140 | Immuchem Covalent-CoatJKC · Traditional | 08/05/1982SE |
| K820329 | Estradiol Kit by RiaCHP · Traditional | 03/04/1982SE |
Questions and answers
When was Covalent Coat Ria Kit cleared by the FDA?
Covalent Coat Ria Kit (K822509) received a 510(k) decision of Substantially Equivalent on September 28, 1982, 39 days after the submission was received.
What is the product code of K822509?
The FDA product code is CFP – Radioimmunoassay, Immunoreactive Insulin, a Class I (low risk) device regulated under 21 CFR 862.1405.