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FDA 510(k)

INDIRECT FLUORESCENT (IFA-ANA)

K-Number: K760681 · 1976-10-21

ApplicantWampole Laboratories
Decision Date1976-10-21
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

INDIRECT FLUORESCENT (IFA-ANA) is the device name listed in this FDA 510(k) record. The listed applicant is Wampole Laboratories. It received FDA 510(k) clearance on 1976-10-21 under 510(k) number K760681. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INDIRECT FLUORESCENT (IFA-ANA)?

INDIRECT FLUORESCENT (IFA-ANA) is a medical device that received FDA 510(k) clearance on 1976-10-21. The listed applicant is Wampole Laboratories. The 510(k) number is K760681.

When did INDIRECT FLUORESCENT (IFA-ANA) receive FDA 510(k) clearance?

INDIRECT FLUORESCENT (IFA-ANA) received FDA 510(k) clearance on 1976-10-21, under 510(k) number K760681.

Who is the listed applicant for INDIRECT FLUORESCENT (IFA-ANA)?

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

What is the FDA product code for INDIRECT FLUORESCENT (IFA-ANA)?

The FDA product code for INDIRECT FLUORESCENT (IFA-ANA) is DHN.

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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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