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FDA 510(k)

AMRAD HEL-PTEST

K-Number: K920827 · 1992-07-14

ApplicantAmrad
Decision Date1992-07-14
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AMRAD HEL-PTEST is the device name listed in this FDA 510(k) record. The listed applicant is Amrad. It received FDA 510(k) clearance on 1992-07-14 under 510(k) number K920827. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMRAD HEL-PTEST?

AMRAD HEL-PTEST is a medical device that received FDA 510(k) clearance on 1992-07-14. The listed applicant is Amrad. The 510(k) number is K920827.

When did AMRAD HEL-PTEST receive FDA 510(k) clearance?

AMRAD HEL-PTEST received FDA 510(k) clearance on 1992-07-14, under 510(k) number K920827.

Who is the listed applicant for AMRAD HEL-PTEST?

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

What is the FDA product code for AMRAD HEL-PTEST?

The FDA product code for AMRAD HEL-PTEST is LYR.

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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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