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510(k) K943072

BETA C COUNTER by Capintec Instruments, Inc. — Product Code KPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1994
Date Received
June 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Dose, Radionuclide
Device Class
Class II
Regulation Number
892.1360
Review Panel
RA
Submission Type

Other clearances by Capintec Instruments, Inc.

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  • K921428 — CAPTUS 500 (May 28, 1992)
  • K910020 — CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS (April 8, 1991)
  • K905796 — DOSE CALIBRATOR (March 18, 1991)

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