510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861823Substantially Equivalent

Gentamicin Sulfate Solution (50Mg Gentamicin)

Flow Laboratories, Inc., Mclean VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861823 is the FDA 510(k) clearance record for GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN), a class I device, cleared for Flow Laboratories, Inc. on under FDA product code JSK (Supplement, Culture Media). FDA records list 57 510(k) clearances for Flow Laboratories, Inc., from to . As of , FDA records show no recalls naming K861823.

Clearance record

Decision date
Received
(8 days to decision)
Product code
JSK Supplement, Culture Media
Regulation
21 CFR 866.2450
Device class
Class I
Review panel
Microbiology
Applicant
Flow Laboratories, Inc. 7655 Old Springhouse Rd., Mclean VA
Third party review
No

Clearances, product code JSK

Trailing 12 months

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

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