Home / 510(k) Clearances / K833521

510(k) K833521

REAGENT TESTS STRIP COMBINATIONS by Syn-Kit, Inc. — Product Code JJB

K833521 is an FDA 510(k) premarket notification submitted by Syn-Kit, Inc. for the device "REAGENT TESTS STRIP COMBINATIONS". The FDA issued a decision of Substantially Equivalent on January 11, 1984. The device falls under product code JJB (Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1115. Syn-Kit, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1984
Date Received
October 11, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
Device Class
Class I
Regulation Number
862.1115
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)
  • K843757 — UROPAPER EIKEN AG (December 18, 1984)
  • K843753 — UROPAPER EIKEN GP (December 18, 1984)
  • K843758 — UROPAPER EIKEN GK (December 18, 1984)
  • K843760 — UROPAPER EIKEN G (December 18, 1984)
  • K843755 — UROPAPER EIKEN 6B (December 18, 1984)

Other clearances for product code JJB

  • K943436 — URINE REAGENT STRIPS-8 PARAMETERS (April 24, 1995)
  • K943008 — BIOSCAN REAGENT STRIPS (August 8, 1994)
  • K873553 — WAKO(TM) PRETEST 8A (September 22, 1987)
  • K862806 — URINE DIAGNOSTIC REAGENT STRIPS (December 4, 1986)

FDA data resources