510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780951Substantially Equivalent

Bio-Monitor Gentamicin

Monitor Science Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780951 is the FDA 510(k) clearance record for BIO-MONITOR GENTAMICIN, a class II device, cleared for Monitor Science Corp. on under FDA product code DKD (Bacillus Subtilis, Microbiological Assay, Gentamicin). FDA records list 6 510(k) clearances for Monitor Science Corp., from to . As of , FDA records show no recalls naming K780951.

Clearance record

Decision date
Received
(66 days to decision)
Product code
DKD Bacillus Subtilis, Microbiological Assay, Gentamicin
Regulation
21 CFR 862.3450
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Monitor Science Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DKD

Trailing 12 months

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

FDA records show no clearances under product code DKD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DKD, 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