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510(k) K791449

AGGLUTINOTEST-BRUCELLA by Volu Sol Medical Industries — Product Code GSO

K791449 is an FDA 510(k) premarket notification submitted by Volu Sol Medical Industries for the device "AGGLUTINOTEST-BRUCELLA". The FDA issued a decision of Substantially Equivalent on September 24, 1979. The device falls under product code GSO (Antigens (Febrile), Agglutination, Brucella Spp.), a Class II device regulated under 21 CFR 866.3085. Volu Sol Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1979
Date Received
August 6, 1979
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 Volu Sol Medical Industries

  • K822128 — VOLU-SOL SINGLE DIFFERENTIAL STAIN (August 5, 1982)
  • K822126 — VOLU-SOL CARNOY FLUID (August 5, 1982)
  • K822129 — VOLU-SOL BOVINS FIXATIVE (August 5, 1982)
  • K822127 — VOLU-SOL ZENKERS FIXATIVE (August 5, 1982)
  • K822037 — VOLU-SOL TAP WATER SUBSTITUTE (August 3, 1982)
  • K822035 — VOLU-SOL GILLS EA (August 3, 1982)
  • K822036 — VOLU-SOL DECALCIFER (August 3, 1982)
  • K822038 — VOLU-SOL ORANGE G-6(GILLS-MOD (August 3, 1982)
  • K812906 — ELVI BICLOT 816 (July 22, 1982)
  • K821540 — HEMATOXYLIN II (June 10, 1982)

Other clearances for product code GSO

  • K972396 — VISTA ANTIGEN BRUCELLA MELITENSIS (August 25, 1997)
  • K972394 — VISTA ANTIGEN BRUCELLA ABORTUS (August 25, 1997)
  • K952139 — SAS BRUCELLA SUIS ANTIGEN (July 18, 1995)
  • K952147 — SAS BRUCELLA ABORTUS ANTIGEN (July 17, 1995)
  • K952136 — SAS SALMONELLA H B ANTIGEN (July 17, 1995)
  • K952135 — SAS SALMONELLA H D ANTIGEN (July 17, 1995)
  • K952140 — SAS BRUCELLA MELTIENSIS ANTIGEN (July 17, 1995)
  • K952137 — SAS SALMONELLA H A ANTIGEN (July 17, 1995)
  • K952131 — SAS FEBRILE ANTIGEN SET (July 17, 1995)
  • K885112 — BRUCELLA IFA* (August 15, 1989)

FDA data resources