510(k) K961510 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ACS FRT4 IMMUNOASSAY
| Applicant | Ciba Corning Diagnostics Corp., Irvine CA, US |
| Decision | Substantially Equivalent, Jun 17, 1996 |
| Received | Apr 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961510
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2017 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Systems Calibrator A Kits,
Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack)
Cat No. 04800840, SMN 10285905 (6 pack - REF) Terminated |
JJX | None listed |
| Jan 10, 2017 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Systems Calibrator A Kits,
Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack)
Cat No. 04800840, SMN 10285905 (6 pack - REF) Terminated |
JJX | None listed |
| Jan 10, 2017 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Systems Calibrator A Kits,
Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack)
Cat No. 04800840, SMN 10285905 (6 pack - REF) Terminated |
JJX | None listed |
| Aug 14, 2013 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF).
For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3 Terminated |
JIS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.