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510(k) K940048

STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION by Solarcare Technologies Corp,Inc. — Product Code DLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1996
Date Received
January 5, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Specific
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

Other clearances by Solarcare Technologies Corp,Inc.

  • K954326 — STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY (July 23, 1996)
  • K954156 — STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY (July 22, 1996)
  • K955905 — STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY (May 30, 1996)
  • K954158 — STC DIAGNOSTICS AUTO-LYTE PH ASSAY (April 30, 1996)
  • K954073 — STC DIAGNOSTICS LSD MICRO-PLATE EIA (November 29, 1995)
  • K954266 — STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY (October 13, 1995)
  • K935565 — OPIATES MICRO-PLATE ASSAY (July 14, 1995)
  • K935573 — AMPHETAMINES MICRO-PLATE EIA (July 14, 1995)
  • K950308 — STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA (April 14, 1995)
  • K944056 — AUTO-LYTE METHADONE DIA (December 29, 1994)

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  • K053108 — DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 (February 16, 2006)
  • K052015 — DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 (September 12, 2005)
  • K033601 — LABONE MICRO-PLATE COTININE EIA (February 10, 2004)