510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K980410Substantially Equivalent

Sle Electrodes and Accessories

Specialized Laboratory Equipment, Ltd., Chico CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980410 is the FDA 510(k) clearance record for SLE ELECTRODES AND ACCESSORIES, a class II device, cleared for Specialized Laboratory Equipment, Ltd. on under FDA product code GXY (Electrode, Cutaneous). FDA records list 2 510(k) clearances for Specialized Laboratory Equipment, Ltd., from to . As of , FDA records show no recalls naming K980410.

Clearance record

Decision date
Received
(261 days to decision)
Product code
GXY Electrode, Cutaneous
Regulation
21 CFR 882.1320
Device class
Class II
Review panel
Neurology
Applicant
Specialized Laboratory Equipment, Ltd. 3407 Bay Ave., Chico CA
510(k) summary
Summary
Third party review
No

Clearances, product code GXY

Trailing 12 months
11 clearances under product code GXY in the twelve months to October 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code GXY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20262
May 20263
June 20262
July 20261
August 20261
September 20260
October 20260