CHOLESTEZYME-V EIKEN— 510(k) K821105

Substantially Equivalent

Syn-Kit, Inc.

FDA 510(k) clearance K821105 for CHOLESTEZYME-V EIKEN, Substantially Equivalent on 1982-05-05. Applicant: Syn-Kit, Inc.. Device class: 1.

Clearance details

Applicant: Syn-Kit, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1982-04-20
Decision date: 1982-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Syn-Kit, Inc.

K861098 — SEROIDEN STREPTO KIT 'EIKEN'1986-08-12
K861631 — SLIDE CULTURE U 'EIKEN'1986-06-10
K854819 — CPR SLIDE EIKEN1986-02-26
K854820 — RA 80 EIKEN1986-01-17
K853276 — ASO SLIDE EIKEN1985-08-20

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