510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K820392Substantially Equivalent

Ortho* Bi-Level Assayed Alcohol Diluen

Ortho Diagnostic Systems, Inc., Carpinteria CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820392 is the FDA 510(k) clearance record for ORTHO* BI-LEVEL ASSAYED ALCOHOL DILUEN, a class I device, cleared for Ortho Diagnostic Systems, Inc. on under FDA product code LAS (Drug Specific Control Materials). FDA records list 126 510(k) clearances for Ortho Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K820392.

Clearance record

Decision date
Received
(22 days to decision)
Product code
LAS Drug Specific Control Materials
Regulation
21 CFR 862.3280
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Ortho Diagnostic Systems, Inc. 125 Mark Ave., Carpinteria CA
Third party review
No

Clearances, product code LAS

Trailing 12 months

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

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