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FDA 510(k)

WAKO LDH CII TEST

K-Number: K842452 · 1984-08-15

ApplicantWako Chemicals USA, Inc.
Decision Date1984-08-15
Product CodeCFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WAKO LDH CII TEST 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 1984-08-15 under 510(k) number K842452. The device is classified under product code CFH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAKO LDH CII TEST?

WAKO LDH CII TEST is a medical device that received FDA 510(k) clearance on 1984-08-15. The listed applicant is Wako Chemicals USA, Inc.. The 510(k) number is K842452.

When did WAKO LDH CII TEST receive FDA 510(k) clearance?

WAKO LDH CII TEST received FDA 510(k) clearance on 1984-08-15, under 510(k) number K842452.

Who is the listed applicant for WAKO LDH CII TEST?

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 LDH CII TEST?

The FDA product code for WAKO LDH CII TEST is CFH.

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

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Related Devices (Code: CFH)

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.

K050790SPOTCHEM II LDH TESTArkray, Inc.K020484CARESIDE LDHCareside, Inc.K895138CLINISTAT LDH REAGENT TESTHeraeus Kulzer, Inc.K894578IQ LDHBd Becton Dickinson Vacutainer Systems PreanalyticK880630LACTATE DEHYDROGENASE (LDH-L)Tech-Co, Inc.K860349LACTATE DEHYDROGENASE (LDH) REAGENT SETSterling Diagnostics, 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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