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510(k) K791453

AGGLUTINOTEST-STAPHYLOLISIN by Volu Sol Medical Industries — Product Code GTN

K791453 is an FDA 510(k) premarket notification submitted by Volu Sol Medical Industries for the device "AGGLUTINOTEST-STAPHYLOLISIN". The FDA issued a decision of Substantially Equivalent on September 24, 1979. The device falls under product code GTN (Antisera, Fluorescent, All Types, Staphylococcus Spp.), a Class I device regulated under 21 CFR 866.3700. 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
Antisera, Fluorescent, All Types, Staphylococcus Spp.
Device Class
Class I
Regulation Number
866.3700
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 GTN

  • K855236 — DIAGNOSTIC REAGENT TST-RPLA (November 4, 1986)
  • K855233 — DIAGNOSTIC REAGENT SET-RPLA (November 4, 1986)
  • K851949 — STAPHAUREX ZL30 (May 22, 1985)

FDA data resources