HCL - 200 BIOCHEMISTRY ANALYZER— 510(k) K964409

Name: FDA 510(k) clearance K964409
Creator: U.S. Food and Drug Administration
Published: 1997-01-22

Substantially Equivalent

Hcl Laboratory Systems, Inc.

FDA 510(k) clearance K964409 for HCL - 200 BIOCHEMISTRY ANALYZER, Substantially Equivalent on 1997-01-22. Applicant: Hcl Laboratory Systems, Inc.. Device class: 1.

Clearance details

Applicant: Hcl Laboratory Systems, Inc.
Product code: Code JJF
Device class: Class 1
Regulation: 21 CFR 862.2170
Advisory panel: Clinical Chemistry
Date received: 1996-11-04
Decision date: 1997-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Escondido, CA, US

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