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510(k) K780179

LIQUID SCINTILLATION COUNTER by Roche Medical Electronics, Inc. — Product Code JJJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1978
Date Received
February 3, 1978
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

Other clearances by Roche Medical Electronics, Inc.

  • K791559 — ROCHE SENSOR ADAPTOR (November 21, 1979)
  • K791037 — FETASONDE LABOR STATUS DISPLAY (September 4, 1979)
  • K791038 — FETASONDE UTERINE ACTIVITY MONITOR (September 4, 1979)
  • K791036 — FETASONDE UTERINE WORK MONITOR (September 4, 1979)
  • K791035 — FETASONDE FETAL ACTIVITY MONITOR (September 4, 1979)
  • K791039 — FETASONDE FETAL HEART RATE VARIABILITY (September 4, 1979)
  • K790761 — FETASONDE MODEL 2108 (June 1, 1979)
  • K790421 — ROCHE LACTATE ANALYZER 640 (May 15, 1979)
  • K782088 — MONITOR, HEART RATE MODEL 105 (January 4, 1979)
  • K782089 — MONITOR, HEART RATE MODEL 103 (January 4, 1979)

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  • 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)