CREATININE TEST, SUPER SEVENTEEN— 510(k) K770643

Substantially Equivalent

Hycel, Inc.

FDA 510(k) clearance K770643 for CREATININE TEST, SUPER SEVENTEEN, Substantially Equivalent on 1977-06-24. Applicant: Hycel, Inc.. Device class: 2.

Clearance details

Applicant: Hycel, Inc.
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1977-04-04
Decision date: 1977-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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