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FDA 510(k)

DIRECT & TOTAL BILIRUBIN SET

K-Number: K855195 · 1986-01-14

ApplicantTechnostics Intl.
Decision Date1986-01-14
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECT & TOTAL BILIRUBIN SET is the device name listed in this FDA 510(k) record. The listed applicant is Technostics Intl.. It received FDA 510(k) clearance on 1986-01-14 under 510(k) number K855195. 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 DIRECT & TOTAL BILIRUBIN SET?

DIRECT & TOTAL BILIRUBIN SET is a medical device that received FDA 510(k) clearance on 1986-01-14. The listed applicant is Technostics Intl.. The 510(k) number is K855195.

When did DIRECT & TOTAL BILIRUBIN SET receive FDA 510(k) clearance?

DIRECT & TOTAL BILIRUBIN SET received FDA 510(k) clearance on 1986-01-14, under 510(k) number K855195.

Who is the listed applicant for DIRECT & TOTAL BILIRUBIN SET?

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

What is the FDA product code for DIRECT & TOTAL BILIRUBIN SET?

The FDA product code for DIRECT & TOTAL BILIRUBIN SET is CIG.

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Other records listing Technostics Intl. 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.

K855188CPK (UV) REAGENT KITK860111URIC ACID REAGENT SETK855190MAGNESIUM REAGENT SETK860110GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SETK860109ENZYMATIC UREA NITROGEN REAGENT SETK860112TOTAL LIPIDS REAGENT SET

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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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