510(k) K922040 ยท GJS Test, Time, Prothrombin
NEOPLASTINE CI PLUS
| Applicant | American Bioproducts Co., Parsippany NJ, US |
| Decision | Substantially Equivalent, Jun 23, 1992 |
| Received | May 1, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922040
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2018 | Diagnostica Stago, Inc. Diagnostica Stago STA Noplastine CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma.
(REF 00667)
The STA - Noplastine CI Plus kits provide reagents fo Terminated |
GJS | None listed |
| Oct 25, 2017 | Diagnostica Stago, Inc. Neoplastine Cl Plus @ (ref.00374)
Product Usage:
Manual or automated determination of the prothrombin time (PT). Terminated |
GJS | None listed |
| Oct 25, 2017 | Diagnostica Stago, Inc. Neoplastine Cl Plus (ref. 00375)
Product Usage:
Manual or automated determination of the prothrombin time (PT). Terminated |
GJS | None listed |
| Oct 25, 2017 | Diagnostica Stago, Inc. STA - Neoplastine Cl Plus (ref. 00606)
Product Usage:
Manual or automated determination of the prothrombin time (PT). Terminated |
GJS | None listed |
| Jul 3, 2007 | Diagnostica Stago, Inc. STA Neoplastine CI Plus (10), (cat. 0667).
12 x 10 ml. in vitro diagnostic for the determination of prothrombin time (PT). Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.