FDA 510(k)

AT-III CALIBRATOR

K-Number: K944279 · 1995-04-07

Decision Date1995-04-07

Product CodeJBQ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

AT-III CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is American Bioproducts Co.. It received FDA 510(k) clearance on 1995-04-07 under 510(k) number K944279. The device is classified under product code JBQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AT-III CALIBRATOR?

AT-III CALIBRATOR is a medical device that received FDA 510(k) clearance on 1995-04-07. The listed applicant is American Bioproducts Co.. The 510(k) number is K944279.

When did AT-III CALIBRATOR receive FDA 510(k) clearance?

AT-III CALIBRATOR received FDA 510(k) clearance on 1995-04-07, under 510(k) number K944279.

Who is the listed applicant for AT-III CALIBRATOR?

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

What is the FDA product code for AT-III CALIBRATOR?

The FDA product code for AT-III CALIBRATOR is JBQ.

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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.