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FDA 510(k)

PROOF (BIOLOGICAL/CHEMICAL INDICATOR)

K-Number: K801109 · 1980-05-30

ApplicantAmsco Co.
Decision Date1980-05-30
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROOF (BIOLOGICAL/CHEMICAL INDICATOR) is the device name listed in this FDA 510(k) record. The listed applicant is Amsco Co.. It received FDA 510(k) clearance on 1980-05-30 under 510(k) number K801109. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROOF (BIOLOGICAL/CHEMICAL INDICATOR)?

PROOF (BIOLOGICAL/CHEMICAL INDICATOR) is a medical device that received FDA 510(k) clearance on 1980-05-30. The listed applicant is Amsco Co.. The 510(k) number is K801109.

When did PROOF (BIOLOGICAL/CHEMICAL INDICATOR) receive FDA 510(k) clearance?

PROOF (BIOLOGICAL/CHEMICAL INDICATOR) received FDA 510(k) clearance on 1980-05-30, under 510(k) number K801109.

Who is the listed applicant for PROOF (BIOLOGICAL/CHEMICAL INDICATOR)?

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

What is the FDA product code for PROOF (BIOLOGICAL/CHEMICAL INDICATOR)?

The FDA product code for PROOF (BIOLOGICAL/CHEMICAL INDICATOR) is JOJ.

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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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