FDA 510(k)

ACTIM PROM AND CONTROLS

K-Number: K061886 · 2007-01-25

Decision Date2007-01-25

Product CodeOAM

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ACTIM PROM AND CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Medix Biochemica. It received FDA 510(k) clearance on 2007-01-25 under 510(k) number K061886. The device is classified under product code OAM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTIM PROM AND CONTROLS?

ACTIM PROM AND CONTROLS is a medical device that received FDA 510(k) clearance on 2007-01-25. The listed applicant is Medix Biochemica. The 510(k) number is K061886.

When did ACTIM PROM AND CONTROLS receive FDA 510(k) clearance?

ACTIM PROM AND CONTROLS received FDA 510(k) clearance on 2007-01-25, under 510(k) number K061886.

Who is the listed applicant for ACTIM PROM AND CONTROLS?

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

What is the FDA product code for ACTIM PROM AND CONTROLS?

The FDA product code for ACTIM PROM AND CONTROLS is OAM.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.