MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL— 510(k) K961042

Name: FDA 510(k) clearance K961042
Creator: U.S. Food and Drug Administration
Published: 1996-05-30

Substantially Equivalent

Dade Microscan, Inc.

FDA 510(k) clearance K961042 for MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL, Substantially Equivalent on 1996-05-30. Applicant: Dade Microscan, Inc.. Device class: 1.

Clearance details

Applicant: Dade Microscan, Inc.
Product code: Code LRH
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1996-03-14
Decision date: 1996-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

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