510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K791453Substantially Equivalent

Agglutinotest-Staphylolisin

Volu Sol Medical Industries, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K791453 is the FDA 510(k) clearance record for AGGLUTINOTEST-STAPHYLOLISIN, a class I device, cleared for Volu Sol Medical Industries on under FDA product code GTN (Antisera, Fluorescent, All Types, Staphylococcus Spp.). FDA records list 66 510(k) clearances for Volu Sol Medical Industries, from to . As of , FDA records show no recalls naming K791453.

Clearance record

Decision date
Received
(49 days to decision)
Product code
GTN Antisera, Fluorescent, All Types, Staphylococcus Spp.
Regulation
21 CFR 866.3700
Device class
Class I
Review panel
Microbiology
Applicant
Volu Sol Medical Industries 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GTN

Trailing 12 months

FDA records hold no clearances under product code GTN in the trailing twelve months.

FDA records show no clearances under product code GTN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GTN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260