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FDA 510(k)

AUTO-CALCIUM REAG FOR GILFORD 3400E ANAL

K-Number: K761029 · 1976-11-30

ApplicantHarleco
Decision Date1976-11-30
Product CodeCJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTO-CALCIUM REAG FOR GILFORD 3400E ANAL is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1976-11-30 under 510(k) number K761029. The device is classified under product code CJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

AUTO-CALCIUM REAG FOR GILFORD 3400E ANAL is a medical device that received FDA 510(k) clearance on 1976-11-30. The listed applicant is Harleco. The 510(k) number is K761029.

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

AUTO-CALCIUM REAG FOR GILFORD 3400E ANAL received FDA 510(k) clearance on 1976-11-30, under 510(k) number K761029.

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

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-CALCIUM REAG FOR GILFORD 3400E ANAL?

The FDA product code for AUTO-CALCIUM REAG FOR GILFORD 3400E ANAL is CJY.

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Related Devices (Code: CJY)

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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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