VISI-CHECK HLH TEST MONOCLONAL— 510(k) K860334

Name: FDA 510(k) clearance K860334
Creator: U.S. Food and Drug Administration
Published: 1986-04-21

Substantially Equivalent

Bioclinical Systems, Inc.

FDA 510(k) clearance K860334 for VISI-CHECK HLH TEST MONOCLONAL, Substantially Equivalent on 1986-04-21. Applicant: Bioclinical Systems, Inc.. Device class: 1.

Clearance details

Applicant: Bioclinical Systems, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1986-01-29
Decision date: 1986-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St.Louis, MO, US

Download summary PDF View on FDA.gov ↗

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