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Carestart Hcg One-Step Pregnancy Test

by Access Bio Incorporate 510(k)

Active United States

510(k) K031052

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK031052 Date13 Jun 2003ClearedStatusActive

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  • Withdrawn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 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DHA
Device Class
Class II
Regulation
21 CFR Part 862.1155
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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