510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081008Substantially Equivalent

Buprenorphine Enzyme Immunoassay, Calibrators and Controls for Beckman Coulter Synchron Systems

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

K081008 is the FDA 510(k) clearance record for BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS, a class II device, cleared for Lin-Zhi International, Inc. on under FDA product code DJG (Enzyme Immunoassay, Opiates). FDA records list 50 510(k) clearances for Lin-Zhi International, Inc., from to . As of , FDA records show 2 recalls naming K081008.

Clearance record

Decision date
Received
(256 days to decision)
Product code
DJG Enzyme Immunoassay, Opiates
Regulation
21 CFR 862.3650
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Lin-Zhi International, Inc. 687 N. Pastoria Ave., Synnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DJG

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