510(k) K922021 ยท GIZ Plasma, Control, Normal
UNICALIBRATOR KIT
| Applicant | American Bioproducts Co., Parsippany NJ, US |
| Decision | Substantially Equivalent, Jun 9, 1992 |
| Received | Apr 30, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922021
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2019 | Diagnostica Stago, Inc. STA UNICALIBRATOR (ref. 00675) Terminated |
GIZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.