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FDA 510(k)

WAKO AUTOKIT CH50

K-Number: K954145 · 1995-12-18

ApplicantWako Chemicals USA, Inc.
Decision Date1995-12-18
Product CodeDAE
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

WAKO AUTOKIT CH50 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 1995-12-18 under 510(k) number K954145. The device is classified under product code DAE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAKO AUTOKIT CH50?

WAKO AUTOKIT CH50 is a medical device that received FDA 510(k) clearance on 1995-12-18. The listed applicant is Wako Chemicals USA, Inc.. The 510(k) number is K954145.

When did WAKO AUTOKIT CH50 receive FDA 510(k) clearance?

WAKO AUTOKIT CH50 received FDA 510(k) clearance on 1995-12-18, under 510(k) number K954145.

Who is the listed applicant for WAKO AUTOKIT CH50?

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 AUTOKIT CH50?

The FDA product code for WAKO AUTOKIT CH50 is DAE.

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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: DAE)

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.

K113349HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FOThe Binding Site Group , Ltd.K992488TOTAL HAEMOLYTIC COMPLEMENT RID KITThe Binding Site, Ltd.K974111QUIDEL CH50 EQ EIAQuidel Corp.K951639COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)Incstar Corp.

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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