ClearanceBrief
510(k) K952337 ยท LCP Assay, Glycosylated Hemoglobin

ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P

ApplicantRoche Diagnostic Systems, Inc., Somerville NJ, US
DecisionSubstantially Equivalent, Feb 9, 1996
ReceivedMay 19, 1995
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K952337

DateFirm and productCodeLinked 510(k)
Mar 23, 2005Roche Diagnostics Corp.
Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number 20755648322.
Terminated		 LCPNone listed
Mar 23, 2005Roche Diagnostics Corp.
Roche ULTIMATE 5 HBA1C test kit for use with MIRA analyzers; catalog number 20755656322.
Terminated		 LCPNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.