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FDA 510(k)

GLUCOSE REAGENT SYSTEM

K-Number: K782136 · 1979-01-26

ApplicantAmerican Monitor Corp.
Decision Date1979-01-26
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE REAGENT SYSTEM 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 1979-01-26 under 510(k) number K782136. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUCOSE REAGENT SYSTEM?

GLUCOSE REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1979-01-26. The listed applicant is American Monitor Corp.. The 510(k) number is K782136.

When did GLUCOSE REAGENT SYSTEM receive FDA 510(k) clearance?

GLUCOSE REAGENT SYSTEM received FDA 510(k) clearance on 1979-01-26, under 510(k) number K782136.

Who is the listed applicant for GLUCOSE REAGENT SYSTEM?

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 GLUCOSE REAGENT SYSTEM?

The FDA product code for GLUCOSE REAGENT SYSTEM is CFR.

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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.

K896000ASPARTATE AMINOTRANFERASE (AST)K895999PHOSPHORUSK896001ALANINE AMINOTRANSFERASE (ALT)K895423ACCESS CHEMISTRY ANALYZERK893137EXCEL (TM) CHEMISTRY ANALYZERK892331ENZYMATIC UREA NITROGEN REAGENT SET

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Related Devices (Code: CFR)

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.

K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche DiagnosticsK252357Glucose2Abbott IrelandK220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSHRoche DiagnosticsK191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche DiagnosticsK170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMAbbott LaboratoriesK153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL IIElitechgroup

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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