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FDA 510(k)

WAKO(TM) PRETEST 5A

K-Number: K873366 · 1988-01-21

ApplicantWako Chemicals USA, Inc.
Decision Date1988-01-21
Product CodeCDM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WAKO(TM) PRETEST 5A is the device name listed in this FDA 510(k) record. The listed applicant is Wako Chemicals USA, Inc.. It received FDA 510(k) clearance on 1988-01-21 under 510(k) number K873366. The device is classified under product code CDM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAKO(TM) PRETEST 5A?

WAKO(TM) PRETEST 5A is a medical device that received FDA 510(k) clearance on 1988-01-21. The listed applicant is Wako Chemicals USA, Inc.. The 510(k) number is K873366.

When did WAKO(TM) PRETEST 5A receive FDA 510(k) clearance?

WAKO(TM) PRETEST 5A received FDA 510(k) clearance on 1988-01-21, under 510(k) number K873366.

Who is the listed applicant for WAKO(TM) PRETEST 5A?

The FDA 510(k) record lists Wako Chemicals USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WAKO(TM) PRETEST 5A?

The FDA product code for WAKO(TM) PRETEST 5A is CDM.

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Other records listing Wako Chemicals USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K100464UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTIONK080125APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201K080123APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201K061775WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATORK062368WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401K053131WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191

View all 123 devices →

Related Devices (Code: CDM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K052719URITEST 10 URINALYSIS REAGENT STRIPSArj Medical, Inc.K061559ACON URINALYSIS REAGENT STRIPSAcon Laboratories Co.K880584URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8CMach Diag. C/O Wichita State UniversityK852611TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINEMiles Laboratories, Inc.K821799FITKIT I CHECKUP KITPatton, Boggs & BlowK830340FITKIT I CHECKUP KITBoditestor

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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