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FDA 510(k)

AUTO-ENZYMATIC GLUCOSE FOR ANALYZER

K-Number: K770886 · 1977-07-14

ApplicantHarleco
Decision Date1977-07-14
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTO-ENZYMATIC GLUCOSE FOR ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1977-07-14 under 510(k) number K770886. 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 FOR ANALYZER?

AUTO-ENZYMATIC GLUCOSE FOR ANALYZER is a medical device that received FDA 510(k) clearance on 1977-07-14. The listed applicant is Harleco. The 510(k) number is K770886.

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

AUTO-ENZYMATIC GLUCOSE FOR ANALYZER received FDA 510(k) clearance on 1977-07-14, under 510(k) number K770886.

Who is the listed applicant for AUTO-ENZYMATIC GLUCOSE FOR ANALYZER?

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 FOR ANALYZER?

The FDA product code for AUTO-ENZYMATIC GLUCOSE FOR ANALYZER 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.

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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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