UROPAPER EIKEN AG— 510(k) K843757

Substantially Equivalent

Syn-Kit, Inc.

FDA 510(k) clearance K843757 for UROPAPER EIKEN AG, Substantially Equivalent on 1984-12-18. Applicant: Syn-Kit, Inc.. Device class: 2.

Clearance details

Applicant: Syn-Kit, Inc.
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 1984-09-25
Decision date: 1984-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIL

K193514 — AUTION MAX AX-4060 Urinalysis System2023-04-13
K183432 — cobas u 601 urinalysis test system2019-05-07
K173327 — DIP/U.S. Urine Analysis Test System2018-07-18
K180356 — inui In-Home Urine Analysis Test System2018-05-25
K181024 — DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips2018-05-23

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.