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510(k) K854685

DIGITAL-9 KEY LEUCOCYTE COUNTER by Future Impex Corp. — Product Code GKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1986
Date Received
November 20, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hand-Tally, Differential
Device Class
Class I
Regulation Number
864.6160
Review Panel
HE
Submission Type

Other clearances by Future Impex Corp.

  • K861487 — ST-90 SPIRO ANALIZER (June 23, 1986)
  • K854686 — TE-25 COAGURO METER (June 4, 1986)
  • K854687 — ERMA HB-METER MODEL 303N (June 4, 1986)
  • K854678 — ERMA PC-602 PC-603 BLOOD CELL COUNTER (February 24, 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)
  • K843700 — ST-200A W/MAXIMAL VOLUNTARY VENTILLAT- (October 24, 1984)
  • K843984 — PM-80 PULMOTESTER (October 24, 1984)
  • K832432 — SPIRO ANALYZER ST-100 AUTOMATIC SPIRO (September 29, 1983)

Other clearances for product code GKM

  • K874188 — COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA (January 19, 1988)
  • K841026 — MANUAL BLOOD CELL COUNTING DEVICE (April 4, 1984)
  • K771580 — TEKTALLY II (September 2, 1977)