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FDA 510(k)

T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL

K-Number: K852008 · 1985-05-30

ApplicantAlpkem Corp.
Decision Date1985-05-30
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL is the device name listed in this FDA 510(k) record. The listed applicant is Alpkem Corp.. It received FDA 510(k) clearance on 1985-05-30 under 510(k) number K852008. 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 T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL?

T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL is a medical device that received FDA 510(k) clearance on 1985-05-30. The listed applicant is Alpkem Corp.. The 510(k) number is K852008.

When did T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL receive FDA 510(k) clearance?

T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL received FDA 510(k) clearance on 1985-05-30, under 510(k) number K852008.

Who is the listed applicant for T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL?

The FDA 510(k) record lists Alpkem Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL?

The FDA product code for T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL is CIG.

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Other records listing Alpkem Corp. 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.

K894011TOTAL GALACTOSEK891070PHENYLALANINE (NINHYDRIN REACTION)K890334TOTAL CHOLESTEROL REAGENTK890337TRIGLYCERIDES - GPO REAGENTK890336GLUCOSE (GOD) REAGENTK890332RFA/2 RAPID FLOW ANALYZER W/COMPUTER

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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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