Platelet Counter & Hematocrit Acces.

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K771353 ↗

FDA Product Code

GKL

Device Class

Class II

Regulation

21 CFR Part 864.5200

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Albumin Test, Hma Albumin Test

  Class II

  FDA 510(k) K771259 Active Cleared 22 Aug 1977

• Hycel Trigyceride II Test

  Not classified

  FDA 510(k) K802422 Active Cleared 6 Oct 1980

• Creatinine Test, Super Seventeen

  Class II

  FDA 510(k) K770643 Active Cleared 24 Jun 1977

• Propane, High Purity, Instrument Grade

  Class I

  FDA 510(k) K770393 Active Cleared 26 Apr 1977

• Royco Model 970 Hematology Data Analyzer

  Class II

  FDA 510(k) K780946 Active Cleared 27 Jul 1978

• Hma Uric Acid Test

  Class I

  FDA 510(k) K781004 Active Cleared 27 Jul 1978

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