510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852158Substantially Equivalent

Bioprobe Fluor Gentamicin in Serum or Plasma

Bioprobe Intl., Inc., Tustin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852158 is the FDA 510(k) clearance record for BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA, a class II device, cleared for Bioprobe Intl., Inc. on under FDA product code LCQ (Fluorescent Immunoassay Gentamicin). FDA records list one 510(k) clearance for Bioprobe Intl., Inc. As of , FDA records show no recalls naming K852158.

Clearance record

Decision date
Received
(39 days to decision)
Product code
LCQ Fluorescent Immunoassay Gentamicin
Regulation
21 CFR 862.3450
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Bioprobe Intl., Inc. 2842 Walnut Ave., Suite C, Tustin CA
Third party review
No

Clearances, product code LCQ

Trailing 12 months

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

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