STAPHAUREX PLUS(TM)— 510(k) K945538

Substantially Equivalent

Murex Diagnostics Limitd

FDA 510(k) clearance K945538 for STAPHAUREX PLUS(TM), Substantially Equivalent on 1995-06-01. Applicant: Murex Diagnostics Limitd. Device class: 1.

Clearance details

Applicant: Murex Diagnostics Limitd
Product code: Code JWX
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1994-11-14
Decision date: 1995-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: England, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWX

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K972030 — STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS1997-09-08
K964315 — REMEL STAPH LATEX KIT1997-02-07
K926173 — STAPH-A-LEX(TM) SYSTEM1993-08-10
K923212 — SLIDEX STAPH-KIT1992-09-28

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