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510(k) K972388

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

K972388 is an FDA 510(k) premarket notification submitted by Lee Laboratories, Inc. for the device "VISTA ANTIGEN SALMONELLA O GROUP C". The FDA issued a decision of Substantially Equivalent on August 25, 1997. The device falls under product code GNC (Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.), a Class II device regulated under 21 CFR 866.3550. 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, 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.

  • 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)
  • K972396 — VISTA ANTIGEN BRUCELLA MELITENSIS (August 25, 1997)
  • K972387 — VISTA ANTIGEN SALMONELLA O GROUP A (August 25, 1997)

Other clearances for product code GNC

  • K972391 — VISTA ANTIGEN SALMONELLA H B (August 25, 1997)
  • K972389 — VISTA ANTIGEN SALMONELLA H D (August 25, 1997)
  • K972390 — VISTA ANTIGEN SALMONELLA H C (August 25, 1997)
  • K972387 — VISTA ANTIGEN SALMONELLA O GROUP A (August 25, 1997)
  • K972386 — VISTA ANTIGEN SALMONELLA O GROUP B (August 25, 1997)
  • K972395 — VISTA ANTIGEN SALMONELLA O GROUP D (August 25, 1997)
  • K972392 — VISTA ANTIGEN SALMONELLA H A (August 25, 1997)
  • K955227 — SAS SPICER-EDWARDS EN COMPLEX ANTISERUM (February 13, 1996)
  • K955224 — SAS SPICER-EDWARDS 2 ANTISERUM (February 13, 1996)
  • K955223 — SAS SPICER-EDWARDS 1 ANTISERUM (February 13, 1996)

FDA data resources