XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX) (K121539) — FDA 510(k) Clearance | Predicase

K-number	K121539
Device name	XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)
Applicant	Cepheid
Product code	NJR
Device class	Class I
Decision date	Nov 2, 2012
Decision	Substantially Equivalent
Regulation	866.3740

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