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FDA 510(k)

HISTOCHEMICAL AFB DEMONSTRATION

K-Number: K771390 · 1977-08-22

ApplicantHarleco
Decision Date1977-08-22
Product CodeICL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HISTOCHEMICAL AFB DEMONSTRATION is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1977-08-22 under 510(k) number K771390. The device is classified under product code ICL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HISTOCHEMICAL AFB DEMONSTRATION?

HISTOCHEMICAL AFB DEMONSTRATION is a medical device that received FDA 510(k) clearance on 1977-08-22. The listed applicant is Harleco. The 510(k) number is K771390.

When did HISTOCHEMICAL AFB DEMONSTRATION receive FDA 510(k) clearance?

HISTOCHEMICAL AFB DEMONSTRATION received FDA 510(k) clearance on 1977-08-22, under 510(k) number K771390.

Who is the listed applicant for HISTOCHEMICAL AFB DEMONSTRATION?

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 HISTOCHEMICAL AFB DEMONSTRATION?

The FDA product code for HISTOCHEMICAL AFB DEMONSTRATION is ICL.

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Related Devices (Code: ICL)

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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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