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FDA 510(k)

AUTO-ENZYMATIC GLUCOSE

K-Number: K761240 · 1976-12-29

ApplicantHarleco
Decision Date1976-12-29
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTO-ENZYMATIC GLUCOSE is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1976-12-29 under 510(k) number K761240. 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 AUTO-ENZYMATIC GLUCOSE?

AUTO-ENZYMATIC GLUCOSE is a medical device that received FDA 510(k) clearance on 1976-12-29. The listed applicant is Harleco. The 510(k) number is K761240.

When did AUTO-ENZYMATIC GLUCOSE receive FDA 510(k) clearance?

AUTO-ENZYMATIC GLUCOSE received FDA 510(k) clearance on 1976-12-29, under 510(k) number K761240.

Who is the listed applicant for AUTO-ENZYMATIC GLUCOSE?

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

What is the FDA product code for AUTO-ENZYMATIC GLUCOSE?

The FDA product code for AUTO-ENZYMATIC GLUCOSE is CFR.

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Other records listing Harleco as applicant

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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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