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510(k) K854679

PHOTIC-100 SPECTROPHOTOMETER by Future Impex Corp. — Product Code JJQ

Clearance Details

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

Device Classification

Device Name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class
Class I
Regulation Number
862.2300
Review Panel
CH
Submission Type

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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)
  • 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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  • K962113 — ANTHOS PHACTS VERSION MICROPLATE READER (November 5, 1996)
  • K961183 — CBI 7520 READER (August 2, 1996)
  • K962166 — ORIGEN ANALYZER (July 31, 1996)
  • K955077 — ANTHOS 2010 READER (December 4, 1995)
  • K953710 — ELX808 AUTOMATED MICROPLATE READERS (October 25, 1995)
  • K953572 — ELX800UV (October 19, 1995)