FDA 510(k)

A3B

K-Number: K834065 · 1983-12-27

Decision Date1983-12-27

Product CodeJSN

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

A3B is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1983-12-27 under 510(k) number K834065. The device is classified under product code JSN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A3B?

A3B is a medical device that received FDA 510(k) clearance on 1983-12-27. The listed applicant is Remel Co.. The 510(k) number is K834065.

When did A3B receive FDA 510(k) clearance?

A3B received FDA 510(k) clearance on 1983-12-27, under 510(k) number K834065.

Who is the listed applicant for A3B?

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 A3B?

The FDA product code for A3B is JSN.

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 DRY K965151A.C.T. III K965150A.C.T. IV K965152A.C.T. II K965149A.C.T. I K960090CALCOFLUOR WHITE STAIN KIT

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Related Devices (Code: JSN)

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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.