Laser-Cal

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K811063 ↗

FDA Product Code

KRX

Device Class

Class II

Regulation

21 CFR Part 864.8150

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Digital Radiography System

  Not classified

  FDA 510(k) K827289 Active Cleared 21 Apr 1982

• Picoscale Blood Cell Counter, Model Ps-5

  Class II

  FDA 510(k) K860166 Active Cleared 4 Apr 1986

• Sickle-Check

  Class II

  FDA 510(k) K820037 Active Cleared 4 Feb 1982

• Lyme-Check(Tm) Test Kit

  Class II

  FDA 510(k) K896378 Active Cleared 5 Nov 1991

• Resubmitted Ebv/Igm-Check Test Kit

  Class I

  FDA 510(k) K890639 Active Cleared 20 Jun 1989

• Bhcg-Check

  Class II

  FDA 510(k) K834346 Active Cleared 4 Feb 1984

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