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Bioclot Apc Sensitivity

by Biopool Intl., Inc. 510(k)

Active United States

510(k) K983898

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK983898 Date6 Jan 1999ClearedStatusActive

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  • Withdrawn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
GGP
Device Class
Class II
Regulation
21 CFR Part 864.7290
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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