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Star Automated Multi-Parametric Analyzer

by American Bioproducts Co.

510(k) K983460

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK983460 Date12 Nov 1998ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0899-03 FDA Unclassified (pre-2012) initiated 5 Mar 2003 on shared 510(k) K983460

    With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
JPA
Device Class
Class II
Regulation
21 CFR Part 864.5425
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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