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510(k) K934376

STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA by Solarcare, Inc. — Product Code DIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1993
Date Received
September 9, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Barbiturate
Device Class
Class II
Regulation Number
862.3150
Review Panel
TX
Submission Type

Other clearances by Solarcare, Inc.

  • K934775 — STC COCAINE METABOLITE EIA (July 14, 1995)
  • K944372 — STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA (February 8, 1995)
  • K941496 — SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY (October 27, 1994)
  • K941497 — SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY (May 24, 1994)
  • K933327 — HISTOFREEZER (October 29, 1993)

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