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510(k) K870029

IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE by American Micro Scan — Product Code GWC

K870029 is an FDA 510(k) premarket notification submitted by American Micro Scan for the device "IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE". The FDA issued a decision of Substantially Equivalent on March 25, 1987. The device falls under product code GWC (Antisera, All Types, Streptococcus Pneumoniae), a Class I device regulated under 21 CFR 866.3740. American Micro Scan has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1987
Date Received
January 5, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Types, Streptococcus Pneumoniae
Device Class
Class I
Regulation Number
866.3740
Review Panel
MI
Submission Type

Other clearances by American Micro Scan

  • K864662 — CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS (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)
  • K860575 — YEAST IDENTIFICATION PANEL (May 13, 1986)

Other clearances for product code GWC

  • K884966 — BACTIGEN(R) S. PNEUMONIAE (February 7, 1989)
  • K884965 — BACTIGEN(R) MENINGITIDIS PANEL (February 7, 1989)
  • K862848 — LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 (December 18, 1986)
  • K842239 — VENTRESCREEN STREP A TEST (July 2, 1984)
  • K841376 — WELLCOGEN S. PNEUMONIAE (May 2, 1984)
  • K831887 — BACTIGEN S. PNEUMONIAE (September 26, 1983)
  • K821960 — BBL PNEUMOSLIDE TEST (July 30, 1982)
  • K802337 — PHADEBACT PNEUMOCOCCUS TEST (October 31, 1980)

FDA data resources