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510(k) K822293

IMMU-COUNT 404 by Kemble Instruments, Inc. — Product Code JJJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1982
Date Received
August 2, 1982
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 Kemble Instruments, Inc.

  • K842894 — KEMBLE 405 (August 27, 1984)
  • K832760 — RIA SOFTWARE (October 14, 1983)
  • K832734 — KEMTEK 400 RIA GAMMA COUNTER (October 14, 1983)
  • K832736 — KEMTEK 104 RIA GAMMA COUNTER (September 29, 1983)
  • K832735 — KEMTEK 103 RIA GAMMA COUNTER (September 29, 1983)
  • K830751 — KEMTEK 102 (April 6, 1983)
  • K827748 — THYRO-COUNT THYROID UPTAKE SYSTEM 90IZD PROBE (August 16, 1982)
  • K820137 — IMMU-COUNT (February 5, 1982)

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)
  • 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)