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FDA 510(k)

CAFFEINE REAGENT DIAZO COLORIMETRY

K-Number: K802630 · 1980-11-26

ApplicantAmerican Monitor Corp.
Decision Date1980-11-26
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CAFFEINE REAGENT DIAZO COLORIMETRY is the device name listed in this FDA 510(k) record. The listed applicant is American Monitor Corp.. It received FDA 510(k) clearance on 1980-11-26 under 510(k) number K802630. 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 CAFFEINE REAGENT DIAZO COLORIMETRY?

CAFFEINE REAGENT DIAZO COLORIMETRY is a medical device that received FDA 510(k) clearance on 1980-11-26. The listed applicant is American Monitor Corp.. The 510(k) number is K802630.

When did CAFFEINE REAGENT DIAZO COLORIMETRY receive FDA 510(k) clearance?

CAFFEINE REAGENT DIAZO COLORIMETRY received FDA 510(k) clearance on 1980-11-26, under 510(k) number K802630.

Who is the listed applicant for CAFFEINE REAGENT DIAZO COLORIMETRY?

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

What is the FDA product code for CAFFEINE REAGENT DIAZO COLORIMETRY?

The FDA product code for CAFFEINE REAGENT DIAZO COLORIMETRY is CIG.

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Other records listing American Monitor 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.

K895999PHOSPHORUSK896000ASPARTATE AMINOTRANFERASE (AST)K896001ALANINE AMINOTRANSFERASE (ALT)K895423ACCESS CHEMISTRY ANALYZERK893137EXCEL (TM) CHEMISTRY ANALYZERK892331ENZYMATIC UREA NITROGEN 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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