Skip to content

Fta-Abs Biopak

by Bioware Products 510(k)

Active United States

510(k) K802276

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK802276 Date23 Oct 1980ClearedStatusActive

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  • Withdrawn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
JWL
Device Class
Class II
Regulation
21 CFR Part 866.3830
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Other devices from Bioware Products