System 8000 Cell Counter

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K850386 ↗

FDA Product Code

GKL

Device Class

Class II

Regulation

21 CFR Part 864.5200

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Spirit Chemistry System

  Class I

  FDA 510(k) K833116 Active Cleared 7 Nov 1983

• System 9000 Automated Cell Counter

  Class II

  FDA 510(k) K870603 Active Cleared 31 Mar 1987

• Encore Chemistry Analyzer

  Class I

  FDA 510(k) K830641 Active Cleared 5 Apr 1983

• Baker Tdm Theophylline Assay

  Class II

  FDA 510(k) K873596 Active Cleared 20 Oct 1987

• Haem-C Plus Blood Reference Controls

  Class II

  FDA 510(k) K821956 Active Cleared 30 Jul 1982

• Ucd Urine Specimen Collector

  Class II

  FDA 510(k) K854173 Active Cleared 4 Nov 1985

See all devices from Baker Instructions Corp. →