510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050988Substantially Equivalent

Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and Controls

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

K050988 is the FDA 510(k) clearance record for OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS, a class I device, cleared for Lin-Zhi International, Inc. on under FDA product code DLG (Coating, Liquid, Glc). FDA records list 50 510(k) clearances for Lin-Zhi International, Inc., from to . As of , FDA records show no recalls naming K050988.

Clearance record

Decision date
Received
(352 days to decision)
Product code
DLG Coating, Liquid, Glc
Regulation
21 CFR 862.2250
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Lin-Zhi International, Inc. 687 N. Pastoria Ave., Synnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DLG

Trailing 12 months

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

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