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FDA 510(k)

GLUCOSE (HEXOKINASE) REAGENT SET

K-Number: K792532 · 1980-01-11

ApplicantMacomb Chemical Co.
Decision Date1980-01-11
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE (HEXOKINASE) REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Macomb Chemical Co.. It received FDA 510(k) clearance on 1980-01-11 under 510(k) number K792532. 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 (HEXOKINASE) REAGENT SET?

GLUCOSE (HEXOKINASE) REAGENT SET is a medical device that received FDA 510(k) clearance on 1980-01-11. The listed applicant is Macomb Chemical Co.. The 510(k) number is K792532.

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

GLUCOSE (HEXOKINASE) REAGENT SET received FDA 510(k) clearance on 1980-01-11, under 510(k) number K792532.

Who is the listed applicant for GLUCOSE (HEXOKINASE) REAGENT SET?

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

What is the FDA product code for GLUCOSE (HEXOKINASE) REAGENT SET?

The FDA product code for GLUCOSE (HEXOKINASE) REAGENT SET is CFR.

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Other records listing Macomb Chemical Co. 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.

K830095RAPID CHEM ANALYZER IIK823720SPECTROPHOTOMETERK810958GLYCOHEMOGLOBINK801086P-NITROPHENYL PHOSPHATEK800719ENZYMATIC UREA NITROGEN REAGENT SET REVIK800720MACOMB NAD-NICOTINAMIDE ADENINE DINUCLEO

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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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