510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K113661Substantially Equivalent

Lzi Methamphetamine Enzyme Mmunoassay, Lzi Methamphetamine Calibrators, Lzi Methamphetamine Controls

Lin-Zhi International Inc, Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113661 is the FDA 510(k) clearance record for LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS, a class II device, cleared for Lin-Zhi International, Inc. on under FDA product code LAF (Gas Chromatography, Methamphetamine). FDA records list 50 510(k) clearances for Lin-Zhi International, Inc., from to . As of , FDA records show no recalls naming K113661.

Clearance record

Decision date
Received
(41 days to decision)
Product code
LAF Gas Chromatography, Methamphetamine
Regulation
21 CFR 862.3610
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Lin-Zhi International, Inc. 670 Almanor Ave., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LAF

Trailing 12 months

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

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