510(k) K932955 ยท JLS Radioimmunoassay, Progesterone
CIBA CORNING ACS PROGESTERONE IMMUNOASSAY
| Applicant | Ciba Corning Diagnostics Corp., East Walpole MA, US |
| Decision | Substantially Equivalent, Aug 2, 1993 |
| Received | Jun 17, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932955
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2017 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111
Product Usage:
The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum an Terminated |
JLS | None listed |
| Jan 4, 2017 | Siemens Healthcare Diagnostics, Inc Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743
Product Usage:
For in vitro diagnostic use in the quantitative determination of progesterone in serum and u Terminated |
JLS | None listed |
| Jan 4, 2017 | Siemens Healthcare Diagnostics, Inc IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128
Product Usage:
For in vitro diagnostic use with the IMMULITE2000 Systems Analyzers- for the quantitative Terminated |
JLS | None listed |
| Jan 4, 2017 | Siemens Healthcare Diagnostics, Inc IMMULITE 2000 Progesterone; Catalog Number: L2KPW2
L2KPW6; Siemens Material Number: 10381181, 10381170
Product Usage:
For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for Terminated |
JLS | None listed |
| Mar 8, 2016 | Siemens Healthcare Diagnostics, Inc Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack
Catalog Number: 04634452
SMN: 10309079
ADVIA Centaur Calibrator E For in vitro diagnostic use in calibration the following assays Terminated |
JIX | None listed |
| Mar 8, 2016 | Siemens Healthcare Diagnostics, Inc Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762
SMN: 10321075
ADVIA Centaur Calibrator E For in vitro diagnostic use in calibration the following assays us Terminated |
JIX | None listed |
| Mar 8, 2016 | Siemens Healthcare Diagnostics, Inc Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference)
Catalog Number: 04636889
SMN: 10335532
ADVIA Centaur Calibrator E For in vitro diagnostic use in calibration the followi Terminated |
JIX | None listed |
| Mar 2, 2015 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Systems Progesterone Kit, (1 -pack)
In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305. Terminated |
JLS | None listed |
| Mar 2, 2015 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522. Terminated |
JLS | None listed |
| Mar 2, 2015 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic
Catalog number: 02177364; SMN: 10333111. Terminated |
JLS | None listed |
| Dec 16, 2014 | Siemens Healthcare Diagnostics, Inc Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref) Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.