510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K881607Substantially Equivalent

Easy-Test Emit(r) Ethosuximide (Eths) Item 16647

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

K881607 is the FDA 510(k) clearance record for EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647, a class II device, cleared for Em Diagnostic Systems, Inc. on under FDA product code DLF (Enzyme Immunoassay, Ethosuximide). FDA records list 288 510(k) clearances for Em Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K881607.

Clearance record

Decision date
Received
(50 days to decision)
Product code
DLF Enzyme Immunoassay, Ethosuximide
Regulation
21 CFR 862.3380
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 DLF

Trailing 12 months

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

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