510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K871329Substantially Equivalent

Easy-Test Emit Gentamicin (Gent) Item No. 16640

Em Diagnostic Systems, Inc., Gibbstown NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871329 is the FDA 510(k) clearance record for EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640, a class II device, cleared for Em Diagnostic Systems, Inc. on under FDA product code LCD (Enzyme Immunoassay, Gentamicin). FDA records list 288 510(k) clearances for Em Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K871329.

Clearance record

Decision date
Received
(39 days to decision)
Product code
LCD Enzyme Immunoassay, Gentamicin
Regulation
21 CFR 862.3450
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Em Diagnostic Systems, Inc. 480 Democrat Rd., Gibbstown NJ
Third party review
No

Clearances, product code LCD

Trailing 12 months

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

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