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FDA 510(k)

WAKO AUTOMATED REAGENTS FOR HITACHI 705

K-Number: K842847 · 1984-12-11

ApplicantWako Chemicals USA, Inc.
Decision Date1984-12-11
Product CodeCJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WAKO AUTOMATED REAGENTS FOR HITACHI 705 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 1984-12-11 under 510(k) number K842847. The device is classified under product code CJW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAKO AUTOMATED REAGENTS FOR HITACHI 705?

WAKO AUTOMATED REAGENTS FOR HITACHI 705 is a medical device that received FDA 510(k) clearance on 1984-12-11. The listed applicant is Wako Chemicals USA, Inc.. The 510(k) number is K842847.

When did WAKO AUTOMATED REAGENTS FOR HITACHI 705 receive FDA 510(k) clearance?

WAKO AUTOMATED REAGENTS FOR HITACHI 705 received FDA 510(k) clearance on 1984-12-11, under 510(k) number K842847.

Who is the listed applicant for WAKO AUTOMATED REAGENTS FOR HITACHI 705?

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 AUTOMATED REAGENTS FOR HITACHI 705?

The FDA product code for WAKO AUTOMATED REAGENTS FOR HITACHI 705 is CJW.

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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

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Related Devices (Code: CJW)

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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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