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510(k) K827748

THYRO-COUNT THYROID UPTAKE SYSTEM 90IZD PROBE by Kemble Instruments, Inc.

K827748 is an FDA 510(k) premarket notification submitted by Kemble Instruments, Inc. for the device "THYRO-COUNT THYROID UPTAKE SYSTEM 90IZD PROBE". The FDA issued a decision of Substantially Equivalent on August 16, 1982. Kemble Instruments, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1982
Date Received
July 20, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • K832735 — KEMTEK 103 RIA GAMMA COUNTER (September 29, 1983)
  • K832736 — KEMTEK 104 RIA GAMMA COUNTER (September 29, 1983)
  • K830751 — KEMTEK 102 (April 6, 1983)
  • K822293 — IMMU-COUNT 404 (August 24, 1982)
  • K820137 — IMMU-COUNT (February 5, 1982)

FDA data resources