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510(k) K870089

IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT by Microscan Div. Baxter Healthcare Corp. — Product Code GTJ

K870089 is an FDA 510(k) premarket notification submitted by Microscan Div. Baxter Healthcare Corp. for the device "IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT". The FDA issued a decision of Substantially Equivalent on March 17, 1987. The device falls under product code GTJ (Antisera, All Groups, N. Meningitidis), a Class II device regulated under 21 CFR 866.3390. Microscan Div. Baxter Healthcare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1987
Date Received
January 9, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Groups, N. Meningitidis
Device Class
Class II
Regulation Number
866.3390
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)
  • K870074 — GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS (April 14, 1987)
  • K871033 — RABBIT KIDNEY CULTURE CELLS (FIRST PASS) (March 31, 1987)

Other clearances for product code GTJ

  • K952791 — DIRECTIGEN MENINGITIS COMBO TEST (May 30, 1996)
  • K915330 — DIRECTIGEN MENINGITIS COMBO TEST KIT (March 23, 1992)
  • K910210 — SLIDEX MENINGITE-KIT 5 (August 12, 1991)
  • K885004 — BACTIGEN(R) N. MENINGITIDIS (February 7, 1989)
  • K854852 — WELLCOGEN BACTERIAL ANTIGEN KIT (February 4, 1986)
  • K854851 — WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24 (February 4, 1986)
  • K844999 — PHADEBACT CSF TEST (October 17, 1985)
  • K851691 — WILLCOGEN MENINGITIDIS KIT ZL25 (June 10, 1985)
  • K844762 — MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51 (June 4, 1985)
  • K844407 — DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST (January 25, 1985)

FDA data resources