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FDA 510(k)

WAKO(TM) PRETEST 8A

K-Number: K873553 · 1987-09-22

ApplicantWako Chemicals USA, Inc.
Decision Date1987-09-22
Product CodeJJB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WAKO(TM) PRETEST 8A 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 1987-09-22 under 510(k) number K873553. The device is classified under product code JJB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAKO(TM) PRETEST 8A?

WAKO(TM) PRETEST 8A is a medical device that received FDA 510(k) clearance on 1987-09-22. The listed applicant is Wako Chemicals USA, Inc.. The 510(k) number is K873553.

When did WAKO(TM) PRETEST 8A receive FDA 510(k) clearance?

WAKO(TM) PRETEST 8A received FDA 510(k) clearance on 1987-09-22, under 510(k) number K873553.

Who is the listed applicant for WAKO(TM) PRETEST 8A?

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 8A?

The FDA product code for WAKO(TM) PRETEST 8A is JJB.

Related Clinical Trials

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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: JJB)

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.

K943436URINE REAGENT STRIPS-8 PARAMETERSTeco DiagnosticsK943008BIOSCAN REAGENT STRIPSGenesis Labs, Inc.K862806URINE DIAGNOSTIC REAGENT STRIPSAmatech International, Inc.K833521REAGENT TESTS STRIP COMBINATIONSSyn-Kit, Inc.

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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