510(k) K972482 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
REAADS PROTEIN S ANTIGEN TEST KIT
| Applicant | Reaads Medical Products, Inc., Westminster CO, US |
| Decision | Substantially Equivalent, Aug 13, 1997 |
| Received | Jul 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972482
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2017 | Helena Laboratories, Inc. "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citrated human plasma Contains: 96 Protein S: Ag Microwells, 3 x 0.5mL ELISA Refer Terminated |
GGP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.