510(k) K083130 ยท NQL System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040
| Applicant | Perkinelmer, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 9, 2009 |
| Received | Oct 23, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083130
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2017 | PerkinElmer Life and Analytical Sciences, Wallac, OY NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184
(01)06438147295708(17)180531(10)653414
(01)06438147295708(17)180531(10)6 Terminated |
NQL | None listed |
| Jan 16, 2013 | Perkinelmer NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U.
This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino Terminated |
NQL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.