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FDA 510(k)

I-L TEST, DIRECT BILIRUBIN SET

K-Number: K850748 · 1985-04-03

ApplicantAllied Instrumentation Laboratory
Decision Date1985-04-03
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

I-L TEST, DIRECT BILIRUBIN SET is the device name listed in this FDA 510(k) record. The listed applicant is Allied Instrumentation Laboratory. It received FDA 510(k) clearance on 1985-04-03 under 510(k) number K850748. 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 I-L TEST, DIRECT BILIRUBIN SET?

I-L TEST, DIRECT BILIRUBIN SET is a medical device that received FDA 510(k) clearance on 1985-04-03. The listed applicant is Allied Instrumentation Laboratory. The 510(k) number is K850748.

When did I-L TEST, DIRECT BILIRUBIN SET receive FDA 510(k) clearance?

I-L TEST, DIRECT BILIRUBIN SET received FDA 510(k) clearance on 1985-04-03, under 510(k) number K850748.

Who is the listed applicant for I-L TEST, DIRECT BILIRUBIN SET?

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

What is the FDA product code for I-L TEST, DIRECT BILIRUBIN SET?

The FDA product code for I-L TEST, DIRECT BILIRUBIN SET is CIG.

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Other records listing Allied Instrumentation Laboratory 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.

K861901MULTI-4 CO-OXIMETER CONTROLK860365PHENOBARBITAL TEST SYSTEMK860286IL TEST PHENYTOINK853858IL TEST THEOPHYLLINE ASSAYK852676IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERSK851933CLINICAL CHEMISTRY ANALYTICAL SYSTEM

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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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