UROPAPER EIKEN 8— 510(k) K843532

Substantially Equivalent

Syn-Kit, Inc.

FDA 510(k) clearance K843532 for UROPAPER EIKEN 8, Substantially Equivalent on 1984-12-12. Applicant: Syn-Kit, Inc.. Device class: 2.

Clearance details

Applicant: Syn-Kit, Inc.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 1984-09-07
Decision date: 1984-12-12
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
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.