RA 80 EIKEN— 510(k) K854820

Substantially Equivalent

Syn-Kit, Inc.

FDA 510(k) clearance K854820 for RA 80 EIKEN, Substantially Equivalent on 1986-01-17. Applicant: Syn-Kit, Inc.. Device class: 2.

Clearance details

Applicant: Syn-Kit, Inc.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1985-12-03
Decision date: 1986-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chatsworth, CA, 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
K853276 — ASO SLIDE EIKEN1985-08-20
K843753 — UROPAPER EIKEN GP1984-12-18

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