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510(k) K935539

CAPINTEC CRC 35R by Capintec Instruments, Inc. — Product Code KPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1994
Date Received
November 16, 1993
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

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  • K910020 — CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS (April 8, 1991)
  • K905796 — DOSE CALIBRATOR (March 18, 1991)

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