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510(k) K946387

CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER by Capintec, Inc. — Product Code JJJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1995
Date Received
November 25, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter (Beta, Gamma) For Clinical Use
Device Class
Class I
Regulation Number
862.2320
Review Panel
CH
Submission Type

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Other clearances for product code JJJ

  • K962762 — SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR (August 16, 1996)
  • K920559 — ABBOTT VERTEX ANALYZER (March 19, 1992)
  • K900087 — GENESYS 6000 GAMMA COUNTER (July 19, 1990)
  • K896202 — MATRIX(TM)-96 (January 2, 1990)
  • K894902 — SOURCERER (October 17, 1989)
  • K884091 — SOURCERER (February 2, 1989)
  • K884269 — SAMPLE IDENTIFICATION STATION MODEL 38010 (January 9, 1989)
  • K874094 — 1205 BETAPLATE LIQUID SCINTILLATION COUNTER (November 4, 1987)
  • K872429 — ISO-DATA 100 SERIES GAMMA COUNTER (August 21, 1987)
  • K872430 — ISO-DATA 500 SERIES GAMMA COUNTER (August 21, 1987)