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Hippurate Disk

by Remel, Inc.

510(k) K801305

Hippurate Disk is a Class I device made by Remel, Inc., cleared under FDA 510(k) K801305 on 21 Jul 1980, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK801305 Date21 Jul 1980ClearedStatusActive

Official records

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  • Withdrawn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
JTC
FDA applicant
Remel Co.
Device class
Class I
Regulation
21 CFR Part 866.2500
Advisory committee
Microbiology
FDA decision
SESE Substantially Equivalent

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