IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS— 510(k) K964009

Name: FDA 510(k) clearance K964009
Creator: U.S. Food and Drug Administration
Published: 1997-02-11

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K964009 for IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS, Substantially Equivalent on 1997-02-11. Applicant: Beckman Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code DNO
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1996-10-07
Decision date: 1997-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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