510(k) K961515 ยท JNB Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
QUANTASE PHENYLALANINE ASSAY
| Applicant | Shield Diagnostics, Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Jun 12, 1996 |
| Received | Apr 10, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961515
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 4, 2011 | Bio-Rad Laboratories Inc Quantase Neonatal Elution Buffer, a component of Quantase Neonatal Accessory Kits (#1, 2 and 5), Model number 532-5035, included in 532-5036, 532-5037 and 532-5040, Manufactured by Bio-Rad Laboratorie Terminated |
JNB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.