510(k) K021541 ยท JNB Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT
| Applicant | Perkinelmer Life Sciences, Norton OH, US |
| Decision | Substantially Equivalent, Oct 28, 2002 |
| Received | May 10, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021541
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2013 | Perkinelmer NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM
MASS SPECTROMETRY KIT
Product Number: 3026-0030.
This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitin Terminated |
JNB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.