Home / 510(k) Clearances / K830751

510(k) K830751

KEMTEK 102 by Kemble Instruments, Inc. — Product Code JJJ

K830751 is an FDA 510(k) premarket notification submitted by Kemble Instruments, Inc. for the device "KEMTEK 102". The FDA issued a decision of Substantially Equivalent on April 6, 1983. The device falls under product code JJJ (Counter (Beta, Gamma) For Clinical Use), a Class I device regulated under 21 CFR 862.2320. Kemble Instruments, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1983
Date Received
March 10, 1983
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)
  • K832734 — KEMTEK 400 RIA GAMMA COUNTER (October 14, 1983)
  • K832760 — RIA SOFTWARE (October 14, 1983)
  • K832736 — KEMTEK 104 RIA GAMMA COUNTER (September 29, 1983)
  • K832735 — KEMTEK 103 RIA GAMMA COUNTER (September 29, 1983)
  • K822293 — IMMU-COUNT 404 (August 24, 1982)
  • 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)
  • K872430 — ISO-DATA 500 SERIES GAMMA COUNTER (August 21, 1987)

FDA data resources