510(k) K982680 ยท MOI System, Test, Immunological, Antigen, Tumor
CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY
| Applicant | Chiron Diagnostics Corp., Medfield MA, US |
| Decision | Substantially Equivalent, Oct 15, 1998 |
| Received | Jul 31, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982680
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2021 | Siemens Healthcare Diagnostics, Inc Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyze Open, Classified |
MOI | None listed |
| Jul 6, 2021 | Siemens Healthcare Diagnostics, Inc Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyze Open, Classified |
MOI | None listed |
| Jul 6, 2021 | Siemens Healthcare Diagnostics, Inc Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellic Open, Classified |
MOI | None listed |
| Mar 8, 2017 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur BR assay
Cat No. 02419937, SMN 10333349 (1-pack/50 tests)
BR Assay for CA 27.29 The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determina Terminated |
MOI | None listed |
| Mar 8, 2017 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur BR assay
Cat No. 03896216, SMN 10334837 (5-pack/250 tests)
BR Assay for CA 27.29 The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determin Terminated |
MOI | None listed |
| Mar 8, 2017 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur BR assay
Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF)
BR Assay for CA 27.29 The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial de Terminated |
MOI | None listed |
| Dec 11, 2012 | Siemens Healthcare Diagnostics, Inc Siemens Healthcare BR Assay for CA 27.29
250 Test Kits 03896216
50 Test Kit 02419937
Ref Kit (US only) 10340081
Intended Use The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantit Terminated |
MOI | None listed |
| Dec 11, 2012 | Siemens Healthcare Diagnostics, Inc Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02)
250 Test 08838753
50 Test 03009619
Intended Use For in vitro diagnostic use in the quantitative determination of theophyl Terminated |
KLS | None listed |
| Oct 28, 2012 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur BR Assay: Catalog Number:
US: REF 02419937 (10214722) (50 Tests);
REF 03896216(10334837)(250 Tests) Not
CE Marked; OUS:
REF03204829(10310271)(50 Tests); REF
01157807(1 0314722) ( Terminated |
MOI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.