CALF (BOVINE) SERUM - STERILE— 510(k) K812383

Name: FDA 510(k) clearance K812383
Creator: U.S. Food and Drug Administration
Published: 1981-09-08

Substantially Equivalent

Dutchland Laboratories, Inc.

FDA 510(k) clearance K812383 for CALF (BOVINE) SERUM - STERILE, Substantially Equivalent on 1981-09-08. Applicant: Dutchland Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Dutchland Laboratories, Inc.
Product code: Code KIS
Device class: Class 1
Regulation: 21 CFR 864.2800
Advisory panel: Hematology
Date received: 1981-08-20
Decision date: 1981-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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