HYCEL COUNTER 333— 510(k) K782100

Substantially Equivalent

Hycel, Inc.

FDA 510(k) clearance K782100 for HYCEL COUNTER 333, Substantially Equivalent on 1979-01-03. Applicant: Hycel, Inc.. Device class: 2.

Clearance details

Applicant: Hycel, Inc.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1978-12-18
Decision date: 1979-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Hycel, Inc.

K802422 — HYCEL TRIGYCERIDE II TEST1980-10-06
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K782116 — KETOSTEROID TEST, HYCEL-171979-01-26
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K782101 — HYCEL COUNTER 2221979-01-03

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