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510(k) K870074

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

K870074 is an FDA 510(k) premarket notification submitted by Microscan Div. Baxter Healthcare Corp. for the device "GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS". The FDA issued a decision of Substantially Equivalent on April 14, 1987. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Microscan Div. Baxter Healthcare Corp. has at least 10 other 510(k) clearances on record.

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.

  • K871228 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2 (June 26, 1987)
  • K871229 — ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL (June 26, 1987)
  • K871233 — ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A (June 26, 1987)
  • K871231 — ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B (June 26, 1987)
  • K871232 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3 (June 26, 1987)
  • K871234 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1 (June 26, 1987)
  • K871230 — ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS (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)

Other clearances for product code JWY

  • K260447 — ETEST Gepotidacin (GEP) (0.016-256 µg/mL) (April 21, 2026)
  • K260696 — MTS Gepotidacin 0.016-256 µg/mL (April 17, 2026)
  • K252114 — MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL (October 2, 2025)
  • K252062 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin (September 25, 2025)
  • K250575 — The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreon (September 5, 2025)
  • K252014 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin (August 28, 2025)
  • K251580 — MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) (August 20, 2025)
  • K250990 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciproflox (June 30, 2025)
  • K242843 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) M (June 20, 2025)
  • K250856 — ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (June 12, 2025)

FDA data resources