ANTI-GBM ANTIBODIES QUANTITATIVE KIT— 510(k) K904181

Name: FDA 510(k) clearance K904181
Creator: U.S. Food and Drug Administration
Published: 1991-09-10

Substantially Equivalent

Biochemical Diagnostic, Inc.

FDA 510(k) clearance K904181 for ANTI-GBM ANTIBODIES QUANTITATIVE KIT, Substantially Equivalent on 1991-09-10. Applicant: Biochemical Diagnostic, Inc.. Device class: 2.

Clearance details

Applicant: Biochemical Diagnostic, Inc.
Product code: Code DBL
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 1990-09-11
Decision date: 1991-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sweden, SE

Download summary PDF View on FDA.gov ↗

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