PASCO MIC AND MIC/ID PANELS, QUINUPRISTIN/DALFOPRISTIN FOR NONFASTIDIOUS ORGANISMS— 510(k) K992726

Name: FDA 510(k) clearance K992726
Creator: U.S. Food and Drug Administration
Published: 1999-11-03

Substantially Equivalent

Pasco Laboratories, Inc.

FDA 510(k) clearance K992726 for PASCO MIC AND MIC/ID PANELS, QUINUPRISTIN/DALFOPRISTIN FOR NONFASTIDIOUS ORGANISMS, Substantially Equivalent on 1999-11-03. Applicant: Pasco Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Pasco Laboratories, Inc.
Product code: Code JTN
Device class: Class 2
Regulation: 21 CFR 866.1620
Advisory panel: Microbiology
Date received: 1999-08-13
Decision date: 1999-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheat Ridge, CO, US

Download summary PDF View on FDA.gov ↗

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