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510(k) K982442

C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) by Care Wise Medical Products Corp. — Product Code IZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1998
Date Received
July 14, 1998
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 Care Wise Medical Products Corp.

  • K922117 — C-TRAK BIOPSY SYSTEM (October 14, 1992)
  • K896588 — ONCOPROBE II SYSTEM (March 14, 1990)
  • K884770 — ONCOPROBE SYSTEM (January 4, 1989)

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  • K942580 — NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES (February 9, 1995)
  • K932153 — THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME (September 7, 1993)