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510(k) K833027

HAEMOPHILUS/NEISSERIA IDENTIF-PANEL by American Micro Scan

K833027 is an FDA 510(k) premarket notification submitted by American Micro Scan for the device "HAEMOPHILUS/NEISSERIA IDENTIF-PANEL". The FDA issued a decision of Substantially Equivalent on October 28, 1983. American Micro Scan has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1983
Date Received
September 7, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by American Micro Scan

  • K864662 — CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS (March 25, 1987)
  • K870029 — IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE (March 25, 1987)
  • K863776 — MICRODILUTION MIC PANELS (February 2, 1987)
  • K864674 — MICRODILUTION IDENTIFICATION PANELS (January 5, 1987)
  • K864389 — CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST (December 4, 1986)
  • K863038 — GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL (September 30, 1986)
  • K862642 — GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL (September 11, 1986)
  • K862332 — ANAEROBE RAPID CHROMOGENIC ID PANEL (August 27, 1986)
  • K862140 — MICRODILUTION PANELS (July 16, 1986)
  • K861584 — GRAM NEGATIVE COMBO PANEL TYPE 3 (June 17, 1986)

FDA data resources