DIABETES RISK DETECTOR— 510(k) K864544

Name: FDA 510(k) clearance K864544
Creator: U.S. Food and Drug Administration
Published: 1987-07-27

Substantially Equivalent

Pearce Clinical Laboratories, Inc.

FDA 510(k) clearance K864544 for DIABETES RISK DETECTOR, Substantially Equivalent on 1987-07-27. Applicant: Pearce Clinical Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Pearce Clinical Laboratories, Inc.
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 1986-11-19
Decision date: 1987-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Conroe, TX, US

Download summary PDF View on FDA.gov ↗

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