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FDA 510(k)

A.C.T. III

K-Number: K965151 · 1997-01-22

ApplicantRemel Co.
Decision Date1997-01-22
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

A.C.T. III is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1997-01-22 under 510(k) number K965151. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A.C.T. III?

A.C.T. III is a medical device that received FDA 510(k) clearance on 1997-01-22. The listed applicant is Remel Co.. The 510(k) number is K965151.

When did A.C.T. III receive FDA 510(k) clearance?

A.C.T. III received FDA 510(k) clearance on 1997-01-22, under 510(k) number K965151.

Who is the listed applicant for A.C.T. III?

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

What is the FDA product code for A.C.T. III?

The FDA product code for A.C.T. III is JSM.

Other records listing Remel Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K013711BACTI-SWAB DRYK965149A.C.T. IK965150A.C.T. IVK965152A.C.T. IIK960090CALCOFLUOR WHITE STAIN KITK960095BACTIDROP CALCOFLUOR WHITE

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Related Devices (Code: JSM)

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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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