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510(k) K950308

STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA by Solarcare Technologies Corp,Inc. — Product Code JXS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1995
Date Received
January 25, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Block, Cutting, Ent, Sterile
Device Class
Class I
Regulation Number
874.3540
Review Panel
EN
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)
  • 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)
  • K935565 — OPIATES MICRO-PLATE ASSAY (July 14, 1995)
  • K935573 — AMPHETAMINES MICRO-PLATE EIA (July 14, 1995)
  • K944056 — AUTO-LYTE METHADONE DIA (December 29, 1994)

Other clearances for product code JXS

  • K822371 — MICRO WORKTABLE (September 9, 1982)