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510(k) K843755

UROPAPER EIKEN 6B by Syn-Kit, Inc. — Product Code JIL

K843755 is an FDA 510(k) premarket notification submitted by Syn-Kit, Inc. for the device "UROPAPER EIKEN 6B". The FDA issued a decision of Substantially Equivalent on December 18, 1984. The device falls under product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)), a Class II device regulated under 21 CFR 862.1340. Syn-Kit, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1984
Date Received
September 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Device Class
Class II
Regulation Number
862.1340
Review Panel
CH
Submission Type

Other clearances by Syn-Kit, Inc.

  • K861098 — SEROIDEN STREPTO KIT 'EIKEN' (August 12, 1986)
  • K861631 — SLIDE CULTURE U 'EIKEN' (June 10, 1986)
  • K854819 — CPR SLIDE EIKEN (February 26, 1986)
  • K854820 — RA 80 EIKEN (January 17, 1986)
  • K853276 — ASO SLIDE EIKEN (August 20, 1985)
  • K843760 — UROPAPER EIKEN G (December 18, 1984)
  • K843757 — UROPAPER EIKEN AG (December 18, 1984)
  • K843753 — UROPAPER EIKEN GP (December 18, 1984)
  • K843758 — UROPAPER EIKEN GK (December 18, 1984)
  • K843759 — UROPAPER EIKEN HAG (December 18, 1984)

Other clearances for product code JIL

  • K193514 — AUTION MAX AX-4060 Urinalysis System (April 13, 2023)
  • K183432 — cobas u 601 urinalysis test system (May 7, 2019)
  • K173327 — DIP/U.S. Urine Analysis Test System (July 18, 2018)
  • K180356 — inui In-Home Urine Analysis Test System (May 25, 2018)
  • K181024 — DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips (May 23, 2018)
  • K171521 — DUS R-50S (Urine Chemistry system) (February 16, 2018)
  • K171083 — iChemVELOCITY Automated Urine Chemistry System (May 12, 2017)
  • K160062 — AUTION ELEVEN Semi-Automated Urinalysis System (October 7, 2016)
  • K160372 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (July 22, 2016)
  • K141289 — TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS (July 24, 2015)

FDA data resources