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510(k) K921428

CAPTUS 500 by Capintec Instruments, Inc. — Product Code IZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1992
Date Received
March 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Uptake, Nuclear
Device Class
Class I
Regulation Number
892.1320
Review Panel
RA
Submission Type

Other clearances by Capintec Instruments, Inc.

  • K943072 — BETA C COUNTER (September 29, 1994)
  • K935539 — CAPINTEC CRC 35R (February 18, 1994)
  • K930962 — CAPTUS 2000 WEL COUNTER (May 18, 1993)
  • K924586 — CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARE (December 3, 1992)
  • K910020 — CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS (April 8, 1991)
  • K905796 — DOSE CALIBRATOR (March 18, 1991)

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