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Proteose No. 3 Agar

by Acumedia Manufacturers, Inc.

510(k) K881552

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK881552 Date18 Apr 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JTY
Device Class
Class II
Regulation
21 CFR Part 866.2410
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Proteose No. 3 Agar is a culture media device used for the isolation of pathogenic Neisseria. It is classified as a Class II medical device under regulation number 866.2410 and product code JTY.

The device received FDA 510(k) clearance (K881552) on April 18, 1988, following a traditional submission. It is manufactured by Acumedia Manufacturers, Inc. and is intended for use in microbiology laboratory settings.

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