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FDA 510(k)

BETA-TEC QUALITATIVE

K-Number: K802999 · 1980-12-22

ApplicantArmkel, LLC
Decision Date1980-12-22
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BETA-TEC QUALITATIVE is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1980-12-22 under 510(k) number K802999. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BETA-TEC QUALITATIVE?

BETA-TEC QUALITATIVE is a medical device that received FDA 510(k) clearance on 1980-12-22. The listed applicant is Armkel, LLC. The 510(k) number is K802999.

When did BETA-TEC QUALITATIVE receive FDA 510(k) clearance?

BETA-TEC QUALITATIVE received FDA 510(k) clearance on 1980-12-22, under 510(k) number K802999.

Who is the listed applicant for BETA-TEC QUALITATIVE?

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

What is the FDA product code for BETA-TEC QUALITATIVE?

The FDA product code for BETA-TEC QUALITATIVE is JHI.

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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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