Product code JKD
- Device name
- Radioimmunoassay, C-Peptides Of Proinsulin
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1135
- 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 |
|---|---|---|---|
| K951848 | AIA-PACK CPR ASSAY | Tosoh Medics, Inc. | 1996-02-13 |
| K943767 | IMMULITE C-PEPTIDE | Diagnostic Products Corp. | 1995-03-23 |
| K896420 | DSL C-PEPTIDE RIA (DSL #7000) | Diagnostic Systems Laboratories, Inc. | 1990-05-24 |
| K854066 | DOUBLE ANTIBODY C-PEPTIDE RIA KIT | Diagnostic Products Corp. | 1985-11-12 |
| K842267 | C-PEP-RIA-100 | Institut National Des Radioelements | 1984-09-06 |
| K833396 | C-PEPTIDE RADIOIMMUNOASSAY TEST KIT | Serono Diagnostics, Inc. | 1984-04-13 |
| K820666 | HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM. | Immuno Nuclear Corp. | 1982-07-13 |
| K812689 | RIA QUANT C-PEPTIDE KIT | Mallinckrodt Critical Care | 1981-10-06 |
| K812288 | HUMAN C-PEPTIDE REAGENTS | Immunex Radiochemical Diagnostics | 1981-08-31 |
| K810718 | C-PEPTICE REAGENTS | Calbiochem-Behring Corp. | 1981-03-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850054026255 | AccuDiag™ C-Peptide ELISA Kit | Diagnostic Automation, Inc. | 2026-01-27 |
| 04048474012934 | C-Peptide ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2024-11-22 |
| 00840239015600 | Proinsulin ELISA | DRG International Inc | 2023-08-23 |
| 15099590733377 | Access C-Peptide | Beckman Coulter, Inc. | 2023-07-28 |
| 06925912718642 | iFlash-C-Peptide | Shenzhen YHLO Biotech Co., Ltd. | 2022-10-26 |
| 00404847412932 | C-Peptide ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| 00404847415605 | Proinsulin ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| 04015630920129 | Elecsys C-Peptide | Roche Diagnostics GmbH | 2021-01-18 |
| B24280CPTHUE100 | ALPCO C-peptide ELISA Jumbo | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2020-09-25 |
| B24280CPTHUCH050 | STELLUX® Chemi Human C-peptide ELISA Lab Pack | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2020-09-25 |
| 00630414953656 | IMMULITE®/IMMULITE® 1000 Systems PEP C-Peptide Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2020-09-24 |
| 00630414953007 | IMMULITE® Systems CPE CONTROL C-Peptide | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2020-09-24 |
| 00630414464053 | ADVIA Centaur® CpS | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00630414600437 | Atellica IM CpS MCM | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00630414600413 | Atellica IM CpS | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00630414953663 | IMMULITE® 2000 Systems PEP C-Peptide Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2020-09-24 |
| 00630414961873 | IMMULITE® 2000 Systems C-Peptide | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2020-09-24 |
| 00630414964430 | IMMULITE®/IMMULITE® 1000 Systems PEP C-Peptide | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2020-09-24 |
| 05400569000049 | C-PEP-EASIA | Diasource Immunoassays S.A. SA | 2020-09-14 |
| B24280PINHUTCH010 | STELLUX® Chemi Human Total Proinsulin ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2020-07-17 |
| B24280CPTHUCH010 | STELLUX® Chemi Human C-peptide ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2020-07-17 |
| B24280CPTHUE010 | ALPCO C-peptide ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2020-07-17 |
| 14560189212227 | AIA-PACK C-Peptide Control Set | TOSOH CORPORATION | 2019-09-02 |
| 04560189212220 | AIA-PACK C-Peptide Control Set | TOSOH CORPORATION | 2019-09-02 |
| 24560189213313 | ST AIA-PACK C-Peptide II | TOSOH CORPORATION | 2019-07-24 |
| 14560189213347 | AIA-PACK C-Peptide II Sample Diluting Solution | TOSOH CORPORATION | 2019-07-24 |
| 04560189213340 | AIA-PACK C-Peptide II Sample Diluting Solution | TOSOH CORPORATION | 2019-07-24 |
| 14560189213316 | ST AIA-PACK C-Peptide II | TOSOH CORPORATION | 2019-07-24 |
| 10758750032037 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2018-01-12 |
| 04015630939992 | Elecsys C-Peptide | Roche Diagnostics GmbH | 2017-04-14 |