PASCO MIC AND MIC/ID PANELS/ CEFDINIR— 510(k) K982156

Name: FDA 510(k) clearance K982156
Creator: U.S. Food and Drug Administration
Published: 1998-07-29

Substantially Equivalent

Pasco Laboratories, Inc.

FDA 510(k) clearance K982156 for PASCO MIC AND MIC/ID PANELS/ CEFDINIR, Substantially Equivalent on 1998-07-29. Applicant: Pasco Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Pasco Laboratories, Inc.
Product code: Code JWJ
Device class: Class 2
Regulation: 21 CFR 888.3800
Advisory panel: Orthopedic
Date received: 1998-06-18
Decision date: 1998-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheat Ridge, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JWJ

product code JWJ

Injury: 181
Total: 181

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.