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510(k) K854686

TE-25 COAGURO METER by Future Impex Corp. — Product Code JBP

Clearance Details

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

Device Classification

Device Name
Activated Whole Blood Clotting Time
Device Class
Class II
Regulation Number
864.7140
Review Panel
HE
Submission Type

Other clearances by Future Impex Corp.

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  • 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)
  • K843984 — PM-80 PULMOTESTER (October 24, 1984)
  • K843700 — ST-200A W/MAXIMAL VOLUNTARY VENTILLAT- (October 24, 1984)
  • K832430 — FUKUNDA SANGYO UNITS ELECTRONIC SPIRO (September 29, 1983)

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