CFP · Radioimmunoassay, Immunoreactive Insulin
Clinical Chemistry · 21 CFR 862.1405 · Class 1
Overview
| Product Code | CFP |
|---|---|
| Device Name | Radioimmunoassay, Immunoreactive Insulin |
| Regulation | 21 CFR 862.1405 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
An immunoreactive insulin test system is a device intended to measure immunoreactive insulin in serum and plasma. Immunoreactive insulin measurements are used in the diagnosis and treatment of various carbohydrate metabolism disorders, including diabetes mellitus, and hypoglycemia.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (20 of 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K963911 | ALPCO/MERCODIA INSULIN ELISA | American Laboratory Products Co., Ltd. | Nov 1, 1996 | SESE |
| K953084 | ACCESS ULTRASENSITIVE INSULIN ASSAY | Bio-Rad Laboratories, Inc. | Sep 25, 1995 | SESE |
| K920109 | IMX INSULIN | Abbott Laboratories | May 7, 1992 | SESE |
| K914820 | DSL INSULIN RIA (DSL 1600) | Diagnostic Systems Laboratories, Inc. | Jan 9, 1992 | SESE |
| K903628 | AIA-PACK IRI | Tosoh Corp. | Sep 7, 1990 | SESE |
| K901135 | ENZYMUN TEST(R) INSULIN | Boehringer Mannheim Corp. | Apr 3, 1990 | SESE |
| K896572 | REP(TM) SPE PLUS-30 PROCEDURES | Helena Laboratories | Jan 11, 1990 | SESE |
| K890837 | RIA-GNOST INSULIN | Cambridge Medical Technology | Apr 26, 1989 | SESE |
| K851071 | PHARMACIA INSULIN RIA | Pharmacia, Inc. | Apr 12, 1985 | SESE |
| K841573 | INSULIN RADIOIMMUNOASSAY KIT | Sorin Biomedica, Fiat, USA, Inc. | May 16, 1984 | SESE |
| K823939 | WAKO INSULIN TEST | Wako Chemicals USA, Inc. | Jan 28, 1983 | SESE |
| K822509 | COVALENT COAT RIA KIT | Immuchem Corp. | Sep 28, 1982 | SESE |
| K821861 | COAT-A-COUNT INSULIN KIT | Diagnostic Products Corp. | Jul 8, 1982 | SESE |
| K821374 | ENZYMUNE-TEST INSULIN | Icl Scientific | May 28, 1982 | SESE |
| K812227 | GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY | Clinical Assays, Inc. | Sep 24, 1981 | SESE |
| K811953 | IMMOPHASE INSULIN (125I) RADIOASSAY | Corning Medical & Scientific | Jul 23, 1981 | SESE |
| K811423 | VENTRE/SEP | Ventrex Laboratories, Inc. | Jun 9, 1981 | SESE |
| K811144 | ARIA II INSULIN RIA | Bd Becton Dickinson Vacutainer Systems Preanalytic | May 15, 1981 | SESE |
| K792279 | AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM | Micromedic Systems | Dec 6, 1979 | SESE |
| K791707 | CENTRIA INSULIN RIA | Ventrex Laboratories, Inc. | Oct 17, 1979 | SESE |
Top Applicants
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 2 clearances
- Micromedic Systems — 2 clearances
- Ventrex Laboratories, Inc. — 2 clearances
- Abbott Laboratories — 1 clearance
- American Laboratory Products Co., Ltd. — 1 clearance
