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510(k) K972386

VISTA ANTIGEN SALMONELLA O GROUP B by Lee Laboratories, Inc. — Product Code GNC

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, Slide And Tube, All Groups, Salmonella Spp.
Device Class
Class II
Regulation Number
866.3550
Review Panel
MI
Submission Type

Other clearances by Lee Laboratories, Inc.

  • K972390 — VISTA ANTIGEN SALMONELLA H C (August 25, 1997)
  • K972395 — VISTA ANTIGEN SALMONELLA O GROUP D (August 25, 1997)
  • K972388 — VISTA ANTIGEN SALMONELLA O GROUP C (August 25, 1997)
  • K972394 — VISTA ANTIGEN BRUCELLA ABORTUS (August 25, 1997)
  • K972392 — VISTA ANTIGEN SALMONELLA H A (August 25, 1997)
  • K972387 — VISTA ANTIGEN SALMONELLA O GROUP A (August 25, 1997)
  • K972396 — VISTA ANTIGEN BRUCELLA MELITENSIS (August 25, 1997)
  • K972389 — VISTA ANTIGEN SALMONELLA H D (August 25, 1997)
  • K972391 — VISTA ANTIGEN SALMONELLA H B (August 25, 1997)

Other clearances for product code GNC

  • K972391 — VISTA ANTIGEN SALMONELLA H B (August 25, 1997)
  • K972388 — VISTA ANTIGEN SALMONELLA O GROUP C (August 25, 1997)
  • K972387 — VISTA ANTIGEN SALMONELLA O GROUP A (August 25, 1997)
  • K972389 — VISTA ANTIGEN SALMONELLA H D (August 25, 1997)
  • K972390 — VISTA ANTIGEN SALMONELLA H C (August 25, 1997)
  • K972395 — VISTA ANTIGEN SALMONELLA O GROUP D (August 25, 1997)
  • K972392 — VISTA ANTIGEN SALMONELLA H A (August 25, 1997)
  • K955223 — SAS SPICER-EDWARDS 1 ANTISERUM (February 13, 1996)
  • K955225 — SAS SPICER-EDWARDS 3 ANTISERUM (February 13, 1996)
  • K955227 — SAS SPICER-EDWARDS EN COMPLEX ANTISERUM (February 13, 1996)