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FDA 510(k)

SYNERMED DIRECT BILIRUBIN REAGENT KIT

K-Number: K933026 · 1993-10-28

ApplicantSynermed, Inc.
Decision Date1993-10-28
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNERMED DIRECT BILIRUBIN REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Synermed, Inc.. It received FDA 510(k) clearance on 1993-10-28 under 510(k) number K933026. 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 SYNERMED DIRECT BILIRUBIN REAGENT KIT?

SYNERMED DIRECT BILIRUBIN REAGENT KIT is a medical device that received FDA 510(k) clearance on 1993-10-28. The listed applicant is Synermed, Inc.. The 510(k) number is K933026.

When did SYNERMED DIRECT BILIRUBIN REAGENT KIT receive FDA 510(k) clearance?

SYNERMED DIRECT BILIRUBIN REAGENT KIT received FDA 510(k) clearance on 1993-10-28, under 510(k) number K933026.

Who is the listed applicant for SYNERMED DIRECT BILIRUBIN REAGENT KIT?

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

What is the FDA product code for SYNERMED DIRECT BILIRUBIN REAGENT KIT?

The FDA product code for SYNERMED DIRECT BILIRUBIN REAGENT KIT is CIG.

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Other records listing Synermed, 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.

K973109SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KITK972716SYNERMED TOTAL BILIRUBIN REAGENT KITK971491SYNERMED IR 200 CHEMISTRY ANALYZERK962479SYNERMED ISE REAGENTSK963939SYNERMED DIRECT BILIRUBIN REAGENT KITK960793SYNERMED ENZYMATIC CO2 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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