Panels › Clinical Chemistry › Product code CFP · Class 1
Radioimmunoassay, Immunoreactive Insulin
Regulation 862.1405
0510(k)s in 12 months (27 all time)
0recalls in 12 months (8 all time)
5recalls that name a 510(k)
Top companies in CFP
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2025 | DRG International, Inc. DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361 Open, Classified |
CFP | None listed |
| Feb 5, 2024 | Beckman Coulter, Inc. Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410 Open, Classified |
CFP | K953084 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK IRI; Part Number: 025260
Assay, Diabetes Terminated |
CFP | None listed |
| Apr 19, 2017 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the quantitative determination of insulin in serum. Terminated |
CFP | K021535 |
| Jun 2, 2012 | Siemens Healthcare Diagnostics IMMULITE 2000 --- Insulin --- Catalog Number: L2KIN2 (200 test), L2KIN6 (600 tests) --- Test Code: INS, Color: Orange ---
Product Usage:
For in vitro diagnostic use with IMMULITE and IMMULITE 1000 S Terminated |
CFP | K022603 |
| Jun 2, 2012 | Siemens Healthcare Diagnostics IMMULITE --- Insulin --- Catalog Number: LKIN1 (100 test), LKIN5 (500 tests) --- Test Code: INS, Color: Orange
Product Usage:
For in vitro diagnostic use with IMMULITE and IMMULITE 1000 Systems Ana Terminated |
CFP | K022603 |
| Jun 25, 2008 | Beckman Coulter Inc Access Ultrasensitive Insulin Assay Kit, Part Number 33410. The product is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of insulin levels in human serum an Terminated |
CFP | K953084 |
| Dec 17, 2004 | Diagnostic Products Corp Immulite 2500 insulin Kit Terminated |
CFP | None listed |
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