510(k) K061792 ยท DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jul 18, 2006 |
| Received | Jun 26, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061792
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Calcium Flex reagent cartridge, Dimension Vista CA, K1023, SMN # 10445160
The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plas Terminated |
CIC | None listed |
| Oct 4, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Calcium (CA) Flex reagent cartridge
Device Listing No.: D011443
Batch Number: 16060BB Terminated |
CIC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.