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FDA 510(k)

TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS

K-Number: K884224 · 1988-12-15

ApplicantA-Kem, Inc.
Decision Date1988-12-15
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is A-Kem, Inc.. It received FDA 510(k) clearance on 1988-12-15 under 510(k) number K884224. 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 TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS?

TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS is a medical device that received FDA 510(k) clearance on 1988-12-15. The listed applicant is A-Kem, Inc.. The 510(k) number is K884224.

When did TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS receive FDA 510(k) clearance?

TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS received FDA 510(k) clearance on 1988-12-15, under 510(k) number K884224.

Who is the listed applicant for TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS?

The FDA 510(k) record lists A-Kem, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS?

The FDA product code for TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS is CIG.

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Other records listing A-Kem, 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.

K884226AMYLASE REAGENT KIT FOR ASTRA SYSTEMSK884225TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMSK884227CALIBRATOR STANDARD KIT FOR ASTRA SYSTEMK882586A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEMK882587A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEMK873132BUN REAGENT KIT

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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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