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Alk-Phos Biopak Gel

by Bioware Products 510(k)

Active United States

510(k) K810144

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK810144 Date2 Feb 1981ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 10 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CIN
Device Class
Class II
Regulation
21 CFR Part 862.1050
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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