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510(k) K883685

IMMUNO/FEBRILE ANTIGENS by Immunostics Co., Inc. — Product Code GNC

K883685 is an FDA 510(k) premarket notification submitted by Immunostics Co., Inc. for the device "IMMUNO/FEBRILE ANTIGENS". The FDA issued a decision of Substantially Equivalent on September 28, 1988. 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. Immunostics Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1988
Date Received
August 29, 1988
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 Immunostics Co., Inc.

  • K926569 — IMMUNO RA UNDILUTED (April 6, 1993)
  • K902360 — HEMA-SCREEN (July 27, 1990)
  • K894780 — IMMUNO/ASO (October 16, 1989)
  • K872910 — IMMUNO/SLE (August 12, 1987)
  • K863741 — IMMUNO-CEPT D (BETA-MONOCLONAL) (November 13, 1986)
  • K854619 — DETECTACULT (March 3, 1986)
  • K853105 — IMMUNO-IM (September 3, 1985)
  • K842110 — SLIDE PREGNANCY TEST (July 12, 1984)
  • K834390 — IMMUNO-CRP (February 3, 1984)
  • K834391 — IMMUNO-RA (February 3, 1984)

Other clearances for product code GNC

  • K972388 — VISTA ANTIGEN SALMONELLA O GROUP C (August 25, 1997)
  • K972392 — VISTA ANTIGEN SALMONELLA H 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)
  • K972387 — VISTA ANTIGEN SALMONELLA O GROUP A (August 25, 1997)
  • K972386 — VISTA ANTIGEN SALMONELLA O GROUP B (August 25, 1997)
  • K972391 — VISTA ANTIGEN SALMONELLA H B (August 25, 1997)
  • K955227 — SAS SPICER-EDWARDS EN COMPLEX ANTISERUM (February 13, 1996)
  • K955224 — SAS SPICER-EDWARDS 2 ANTISERUM (February 13, 1996)

FDA data resources