CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18— 510(k) K880868

Name: FDA 510(k) clearance K880868
Creator: U.S. Food and Drug Administration
Published: 1988-11-01

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K880868 for CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18, Substantially Equivalent on 1988-11-01. Applicant: Diagnostic Chemicals, Ltd. (Usa). Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals, Ltd. (Usa)
Product code: Code KHS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 1988-03-01
Decision date: 1988-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monroe, CT, US

Download summary PDF View on FDA.gov ↗

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