510(k) K022603 ยท CEW Radioimmunoassay, Parathyroid Hormone
IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Aug 21, 2002 |
| Received | Aug 6, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K022603
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.