CARESIDE ANALYZER— 510(k) K982118

Substantially Equivalent

Exigent Diagnostics, Inc.

FDA 510(k) clearance K982118 for CARESIDE ANALYZER, Substantially Equivalent on 1998-07-24. Applicant: Exigent Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Exigent Diagnostics, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1998-06-03
Decision date: 1998-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Exigent Diagnostics, Inc.

K981899 — CARESIDE HDL-CHOLESTEROL1998-07-14
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K980057 — CARESIDE BUN1998-02-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.