Product code CFP
- Device name
- Radioimmunoassay, Immunoreactive Insulin
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1405
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K963911 | ALPCO/MERCODIA INSULIN ELISA | American Laboratory Products Co., Ltd. | 1996-11-01 |
| K953084 | ACCESS ULTRASENSITIVE INSULIN ASSAY | Bio-Rad Laboratories, Inc. | 1995-09-25 |
| K920109 | IMX INSULIN | Abbott Laboratories | 1992-05-07 |
| K914820 | DSL INSULIN RIA (DSL 1600) | Diagnostic Systems Laboratories, Inc. | 1992-01-09 |
| K903628 | AIA-PACK IRI | Tosoh Corp. | 1990-09-07 |
| K901135 | ENZYMUN TEST(R) INSULIN | Boehringer Mannheim Corp. | 1990-04-03 |
| K896572 | REP(TM) SPE PLUS-30 PROCEDURES | Helena Laboratories | 1990-01-11 |
| K890837 | RIA-GNOST INSULIN | Cambridge Medical Technology | 1989-04-26 |
| K851071 | PHARMACIA INSULIN RIA | Pharmacia, Inc. | 1985-04-12 |
| K841573 | INSULIN RADIOIMMUNOASSAY KIT | Sorin Biomedica, Fiat, USA, Inc. | 1984-05-16 |
| K823939 | WAKO INSULIN TEST | Wako Chemicals USA, Inc. | 1983-01-28 |
| K822509 | COVALENT COAT RIA KIT | Immuchem Corp. | 1982-09-28 |
| K821861 | COAT-A-COUNT INSULIN KIT | Diagnostic Products Corp. | 1982-07-08 |
| K821374 | ENZYMUNE-TEST INSULIN | Icl Scientific | 1982-05-28 |
| K812227 | GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY | Clinical Assays, Inc. | 1981-09-24 |
| K811953 | IMMOPHASE INSULIN (125I) RADIOASSAY | Corning Medical & Scientific | 1981-07-23 |
| K811423 | VENTRE/SEP | Ventrex Laboratories, Inc. | 1981-06-09 |
| K811144 | ARIA II INSULIN RIA | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-05-15 |
| K792279 | AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM | Micromedic Systems | 1979-12-06 |
| K791707 | CENTRIA INSULIN RIA | Ventrex Laboratories, Inc. | 1979-10-17 |
| K790630 | RIA, INSULIN, DOUBLE ANTIBODY | Endocrine-Metabolic Center | 1979-07-24 |
| K781285 | INSULIN RIA KIT | Serono Laboratories, Inc. | 1978-08-14 |
| K781086 | INSULIN AUTOPAK | Micromedic Systems | 1978-08-14 |
| K771947 | INSULIN RIA MODULE | Inter Science Institute | 1978-01-20 |
| K772281 | RSL INSULIN KIT | Radioassay Systems Laboratories, Inc. | 1978-01-06 |
| K771979 | CENTRIA INSULIN RIA | Union Carbide Corp. | 1977-11-17 |
| K771628 | NSULIN RIA KIT 125I | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-09-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850049545723 | AccuDiag™ Insulin ELISA | Diagnostic Automation, Inc. | 2026-01-27 |
| 00859410006269 | Salimetrics | SALIMETRICS, LLC | 2024-09-18 |
| 00859410006276 | Salimetrics | SALIMETRICS, LLC | 2024-09-18 |
| 04048474053616 | Insulin | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-09-01 |
| 04048474036084 | Anti-Insulin ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-31 |
| 04048474029352 | Insulin ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 00840239053619 | Insulin | DRG International Inc | 2023-08-26 |
| 00840239036087 | Anti-Insulin ELISA | DRG International Inc | 2023-08-25 |
| 00840239029355 | Insulin ELISA | DRG International Inc | 2023-08-24 |
| 06925912718871 | iFlash-Insulin | Shenzhen YHLO Biotech Co., Ltd. | 2022-10-26 |
| 00404847453614 | Insulin | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| 00404847429350 | Insulin ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| 00404847436082 | Anti-Insulin ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| B24280INSHUCH100 | STELLUX® Chemi Human Insulin ELISA Jumbo | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2020-09-25 |
| B24280INSHUE010 | ALPCO Insulin ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2020-09-25 |
| B24280INSHUE100 | ALPCO Insulin ELISA Jumbo | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2020-09-25 |
| B24280INSHUUE010 | ALPCO Ultrasensitive Insulin ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2020-09-25 |
| B24280INSHUUE100 | ALPCO Ultrasensitive Insulin ELISA Jumbo | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2020-09-25 |
| 00630414466187 | ADVIA Centaur® IRI DIL | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00630414461021 | ADVIA Centaur® IRI | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 24560189210411 | ST AIA-PACK IRI | TOSOH CORPORATION | 2019-07-24 |
| 14560189212760 | AIA-PACK IRI CONTROL SET | TOSOH CORPORATION | 2019-07-24 |
| 14560189211404 | AIA-PACK IRI CALIBRATOR SET | TOSOH CORPORATION | 2019-07-24 |
| 14560189211398 | AIA-PACK IRI SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | 2019-07-24 |
| 04560189212763 | AIA-PACK IRI CONTROL SET | TOSOH CORPORATION | 2019-07-24 |
| 04560189211407 | AIA-PACK IRI CALIBRATOR SET | TOSOH CORPORATION | 2019-07-24 |
| 04560189211391 | AIA-PACK IRI SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | 2019-07-24 |
| 14560189210414 | ST AIA-PACK IRI | TOSOH CORPORATION | 2019-07-24 |
| 10758750032068 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2018-01-12 |
| 04015630940042 | Elecsys Insulin | Roche Diagnostics GmbH | 2017-04-14 |