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FDA 510(k)

WAKO CH50 LINEARITY SET

K-Number: K973055 · 1997-09-25

ApplicantWako Chemicals USA, Inc.
Decision Date1997-09-25
Product CodeJIW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WAKO CH50 LINEARITY SET 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 1997-09-25 under 510(k) number K973055. The device is classified under product code JIW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAKO CH50 LINEARITY SET?

WAKO CH50 LINEARITY SET is a medical device that received FDA 510(k) clearance on 1997-09-25. The listed applicant is Wako Chemicals USA, Inc.. The 510(k) number is K973055.

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

WAKO CH50 LINEARITY SET received FDA 510(k) clearance on 1997-09-25, under 510(k) number K973055.

Who is the listed applicant for WAKO CH50 LINEARITY SET?

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 CH50 LINEARITY SET?

The FDA product code for WAKO CH50 LINEARITY SET is JIW.

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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 999-05401K053132WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791

View all 123 devices →

Related Devices (Code: JIW)

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.

K970396HUMAN CHORIONIC GONADOTROPIN CALIBRATORDade Chemistry Systems, Inc.K910255FLOW CYTOMETRY FITC/PE COMPENSATION KITSigma Diagnostics, Inc.K902575SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)Diagnostic Products Corp.K902294ACCUSCAN MICROBEAD STANDARDSSigma Chemical Co.K892213ACS COLLOID OSMOTIC PRESSURE CALIBRATORAnalytical Control Systems, Inc.K883389RAICHEM(TM) BILIRUBIN CONJUGATE STANDARDReagents Applications, 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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