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510(k) K884269

SAMPLE IDENTIFICATION STATION MODEL 38010 by Icn Micromedic Systems — Product Code JJJ

K884269 is an FDA 510(k) premarket notification submitted by Icn Micromedic Systems for the device "SAMPLE IDENTIFICATION STATION MODEL 38010". The FDA issued a decision of Substantially Equivalent on January 9, 1989. The device falls under product code JJJ (Counter (Beta, Gamma) For Clinical Use), a Class I device regulated under 21 CFR 862.2320. Icn Micromedic Systems has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1989
Date Received
October 11, 1988
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 Icn Micromedic Systems

  • K883746 — MICROMEDIC FERRITIN IRMA KIT (October 27, 1988)
  • K880674 — MICROMEDIC CRACKPOT RIA KIT (October 6, 1988)
  • K881102 — MICROMEDIC MORPHINE RIA KIT (June 24, 1988)

Other clearances for product code JJJ

  • K962762 — SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR (August 16, 1996)
  • K946387 — CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER (March 30, 1995)
  • 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)
  • K874094 — 1205 BETAPLATE LIQUID SCINTILLATION COUNTER (November 4, 1987)
  • K872430 — ISO-DATA 500 SERIES GAMMA COUNTER (August 21, 1987)
  • K872429 — ISO-DATA 100 SERIES GAMMA COUNTER (August 21, 1987)

FDA data resources