Home / 510(k) Clearances / K873553

510(k) K873553

WAKO(TM) PRETEST 8A by Wako Chemicals USA, Inc. — Product Code JJB

K873553 is an FDA 510(k) premarket notification submitted by Wako Chemicals USA, Inc. for the device "WAKO(TM) PRETEST 8A". The FDA issued a decision of Substantially Equivalent on September 22, 1987. 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. Wako Chemicals USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1987
Date Received
August 28, 1987
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 Wako Chemicals USA, Inc.

  • K100464 — UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, (February 23, 2011)
  • K080125 — APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 (July 18, 2008)
  • K080123 — APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 (July 17, 2008)
  • K061775 — WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR (February 23, 2007)
  • K062368 — WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP (January 31, 2007)
  • K053132 — WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 (December 30, 2005)
  • K053131 — WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 (December 30, 2005)
  • DEN050002 — LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS (May 19, 2005)
  • K042551 — MULTI-CHEM CALIBRATOR A (November 16, 2004)
  • K042550 — MULTI-LIPID CALIBRATOR (November 8, 2004)

Other clearances for product code JJB

  • K943436 — URINE REAGENT STRIPS-8 PARAMETERS (April 24, 1995)
  • K943008 — BIOSCAN REAGENT STRIPS (August 8, 1994)
  • K862806 — URINE DIAGNOSTIC REAGENT STRIPS (December 4, 1986)
  • K833521 — REAGENT TESTS STRIP COMBINATIONS (January 11, 1984)

FDA data resources