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FDA 510(k)

BILIRUBIN TESTER

K-Number: K870095 · 1987-06-03

ApplicantWako Chemicals USA, Inc.
Decision Date1987-06-03
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BILIRUBIN TESTER 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 1987-06-03 under 510(k) number K870095. The device is classified under product code CIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BILIRUBIN TESTER?

BILIRUBIN TESTER is a medical device that received FDA 510(k) clearance on 1987-06-03. The listed applicant is Wako Chemicals USA, Inc.. The 510(k) number is K870095.

When did BILIRUBIN TESTER receive FDA 510(k) clearance?

BILIRUBIN TESTER received FDA 510(k) clearance on 1987-06-03, under 510(k) number K870095.

Who is the listed applicant for BILIRUBIN TESTER?

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 BILIRUBIN TESTER?

The FDA product code for BILIRUBIN TESTER is CIG.

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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: CIG)

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.

K251998Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc.K222104Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.K223324Total Bilirubin2Abbott Ireland Diagnostics DivisionK190807VITROS XT Chemistry Products TBIL-ALKP SlidesOrtho-Clinical Diagnostics, Inc.K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1Elitechgroup

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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