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510(k) K924114

HISTOFREEZER by Solarcare Technologies Corp,Inc. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1993
Date Received
August 5, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type

Other clearances by Solarcare Technologies Corp,Inc.

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  • K955905 — STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY (May 30, 1996)
  • K954158 — STC DIAGNOSTICS AUTO-LYTE PH ASSAY (April 30, 1996)
  • K940048 — STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION (March 19, 1996)
  • K954073 — STC DIAGNOSTICS LSD MICRO-PLATE EIA (November 29, 1995)
  • K954266 — STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY (October 13, 1995)
  • K935573 — AMPHETAMINES MICRO-PLATE EIA (July 14, 1995)
  • K935565 — OPIATES MICRO-PLATE ASSAY (July 14, 1995)
  • K950308 — STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA (April 14, 1995)

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