UREA— 510(k) K971309

Substantially Equivalent

Derma Media Lab., Inc.

FDA 510(k) clearance K971309 for UREA, Substantially Equivalent on 1997-08-01. Applicant: Derma Media Lab., Inc.. Device class: 2.

Clearance details

Applicant: Derma Media Lab., Inc.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1997-04-08
Decision date: 1997-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Fe Springs, CA, US

Download summary PDF View on FDA.gov ↗

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