NAPA EIA ASSAY— 510(k) K983812

Substantially Equivalent

Diagnostic Reagents, Inc.

FDA 510(k) clearance K983812 for NAPA EIA ASSAY, Substantially Equivalent on 1998-11-16. Applicant: Diagnostic Reagents, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostic Reagents, Inc.
Product code: Code LAN
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1998-10-28
Decision date: 1998-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Diagnostic Reagents, Inc.

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K983323 — DIGOXIN IMMUNOASSAY1998-11-12
K983280 — VANCOMYCIN EIA ASSAY1998-11-06
K983159 — DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS1998-11-05
K973102 — LIDOCAINE EIA ASSAY1997-09-12

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