CARESIDE GLOBULIN— 510(k) K980055

Substantially Equivalent

Exigent Diagnostics, Inc.

FDA 510(k) clearance K980055 for CARESIDE GLOBULIN, Substantially Equivalent on 1998-01-28. Applicant: Exigent Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Exigent Diagnostics, Inc.
Product code: Code JGE
Device class: Class 1
Regulation: 21 CFR 862.1330
Advisory panel: Clinical Chemistry
Date received: 1998-01-06
Decision date: 1998-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

More clearances from Exigent Diagnostics, Inc.

K982118 — CARESIDE ANALYZER1998-07-24
K981899 — CARESIDE HDL-CHOLESTEROL1998-07-14
K981183 — CARESIDE GLUCOSE1998-05-07
K980043 — CARESIDE CREATININE1998-03-30
K980056 — CARESIDE ANALYZER1998-03-06

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