KETOSTEROID TEST, HYCEL-17— 510(k) K782116

Substantially Equivalent

Hycel, Inc.

FDA 510(k) clearance K782116 for KETOSTEROID TEST, HYCEL-17, Substantially Equivalent on 1979-01-26. Applicant: Hycel, Inc.. Device class: 1.

Clearance details

Applicant: Hycel, Inc.
Product code: Code CCY
Device class: Class 1
Regulation: 21 CFR 862.1430
Advisory panel: Clinical Chemistry
Date received: 1978-12-27
Decision date: 1979-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K782100 — HYCEL COUNTER 3331979-01-03
K782101 — HYCEL COUNTER 2221979-01-03

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