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FDA 510(k)

HEMOCCULT-C

K-Number: K832311 · 1984-02-27

ApplicantMenley & James Laboratories
Decision Date1984-02-27
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCCULT-C is the device name listed in this FDA 510(k) record. The listed applicant is Menley & James Laboratories. It received FDA 510(k) clearance on 1984-02-27 under 510(k) number K832311. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOCCULT-C?

HEMOCCULT-C is a medical device that received FDA 510(k) clearance on 1984-02-27. The listed applicant is Menley & James Laboratories. The 510(k) number is K832311.

When did HEMOCCULT-C receive FDA 510(k) clearance?

HEMOCCULT-C received FDA 510(k) clearance on 1984-02-27, under 510(k) number K832311.

Who is the listed applicant for HEMOCCULT-C?

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

What is the FDA product code for HEMOCCULT-C?

The FDA product code for HEMOCCULT-C is KHE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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