510(k) K955644 ยท KLT Enzyme Immunoassay, Carbamazepine
SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM
| Applicant | Beckman Instruments, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Feb 16, 1996 |
| Received | Dec 12, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955644
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2012 | Beckman Coulter Inc. Synchron Phenobarbital (PHE) Drug Calibrator 1, P/N 469600,
Classification Product Code: KLT.
Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN.
The Beckman Coulter SYNCHRON Systems DRUG CAL Terminated |
DLZ | None listed |
| Mar 6, 2012 | Beckman Coulter Inc. Synchron Phenobarbital (PHE) Reagent, P/N 469785,
Classification Product Code: KLT.
Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN.
PHE reagent, when used in conjunction with SYNCHRON LX Terminated |
DKB | None listed |
| Sep 20, 2010 | Beckman Coulter Inc. SYNCHRON Gentamicin (GEN) Reagent
GEN reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Drug Calibrator 3 Plus, is intended for quantitati Terminated |
LCD | None listed |
| Jul 20, 2004 | Beckman Coulter Inc Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid). Terminated |
KLT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.