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FDA 510(k)

AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL

K-Number: K761026 · 1976-11-30

ApplicantHarleco Diagnostics
Decision Date1976-11-30
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL is the device name listed in this FDA 510(k) record. The listed applicant is Harleco Diagnostics. It received FDA 510(k) clearance on 1976-11-30 under 510(k) number K761026. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL?

AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL is a medical device that received FDA 510(k) clearance on 1976-11-30. The listed applicant is Harleco Diagnostics. The 510(k) number is K761026.

When did AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL receive FDA 510(k) clearance?

AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL received FDA 510(k) clearance on 1976-11-30, under 510(k) number K761026.

Who is the listed applicant for AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL?

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

What is the FDA product code for AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL?

The FDA product code for AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL is CIX.

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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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