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510(k) K854678

ERMA PC-602 PC-603 BLOOD CELL COUNTER by Future Impex Corp. — Product Code GKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1986
Date Received
December 5, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Cell, Automated (Particle Counter)
Device Class
Class II
Regulation Number
864.5200
Review Panel
HE
Submission Type

Other clearances by Future Impex Corp.

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  • K854685 — DIGITAL-9 KEY LEUCOCYTE COUNTER (April 4, 1986)
  • K854677 — ERMA PC-604 BLOOD CELL COUNTER (February 24, 1986)
  • K854679 — PHOTIC-100 SPECTROPHOTOMETER (February 20, 1986)
  • K843934 — MODEL {M-102 I-CHANNEL ELECTRO CARDIOGRAPH UNIT (November 20, 1984)
  • K843984 — PM-80 PULMOTESTER (October 24, 1984)
  • K843700 — ST-200A W/MAXIMAL VOLUNTARY VENTILLAT- (October 24, 1984)
  • K832433 — AUTOMATIC SPIROMETER ST-200 (September 29, 1983)

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