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510(k) K870074

GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS by Microscan Div. Baxter Healthcare Corp. — Product Code JWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1987
Date Received
January 8, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manual Antimicrobial Susceptibility Test Systems
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

Other clearances by Microscan Div. Baxter Healthcare Corp.

  • K871229 — ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL (June 26, 1987)
  • K871228 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2 (June 26, 1987)
  • K871232 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3 (June 26, 1987)
  • K871231 — ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B (June 26, 1987)
  • K871233 — ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A (June 26, 1987)
  • K871230 — ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS (June 26, 1987)
  • K871234 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1 (June 26, 1987)
  • K870814 — HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2 (June 4, 1987)
  • K871033 — RABBIT KIDNEY CULTURE CELLS (FIRST PASS) (March 31, 1987)
  • K870089 — IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT (March 17, 1987)

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