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510(k) K972396

VISTA ANTIGEN BRUCELLA MELITENSIS by Lee Laboratories, Inc. — Product Code GSO

K972396 is an FDA 510(k) premarket notification submitted by Lee Laboratories, Inc. for the device "VISTA ANTIGEN BRUCELLA MELITENSIS". The FDA issued a decision of Substantially Equivalent on August 25, 1997. The device falls under product code GSO (Antigens (Febrile), Agglutination, Brucella Spp.), a Class II device regulated under 21 CFR 866.3085. Lee Laboratories, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1997
Date Received
June 26, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens (Febrile), Agglutination, Brucella Spp.
Device Class
Class II
Regulation Number
866.3085
Review Panel
MI
Submission Type

Other clearances by Lee Laboratories, Inc.

  • K972386 — VISTA ANTIGEN SALMONELLA O GROUP B (August 25, 1997)
  • K972391 — VISTA ANTIGEN SALMONELLA H B (August 25, 1997)
  • K972394 — VISTA ANTIGEN BRUCELLA ABORTUS (August 25, 1997)
  • K972392 — VISTA ANTIGEN SALMONELLA H A (August 25, 1997)
  • K972395 — VISTA ANTIGEN SALMONELLA O GROUP D (August 25, 1997)
  • K972389 — VISTA ANTIGEN SALMONELLA H D (August 25, 1997)
  • K972390 — VISTA ANTIGEN SALMONELLA H C (August 25, 1997)
  • K972388 — VISTA ANTIGEN SALMONELLA O GROUP C (August 25, 1997)
  • K972387 — VISTA ANTIGEN SALMONELLA O GROUP A (August 25, 1997)

Other clearances for product code GSO

  • K972394 — VISTA ANTIGEN BRUCELLA ABORTUS (August 25, 1997)
  • K952139 — SAS BRUCELLA SUIS ANTIGEN (July 18, 1995)
  • K952131 — SAS FEBRILE ANTIGEN SET (July 17, 1995)
  • K952147 — SAS BRUCELLA ABORTUS ANTIGEN (July 17, 1995)
  • K952136 — SAS SALMONELLA H B ANTIGEN (July 17, 1995)
  • K952140 — SAS BRUCELLA MELTIENSIS ANTIGEN (July 17, 1995)
  • K952137 — SAS SALMONELLA H A ANTIGEN (July 17, 1995)
  • K952135 — SAS SALMONELLA H D ANTIGEN (July 17, 1995)
  • K885112 — BRUCELLA IFA* (August 15, 1989)
  • K822663 — FEBRILE ANTIGEN KIT (September 21, 1982)

FDA data resources