510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981314Substantially Equivalent

Visualine II (Also Known as Sunline) Methadone

Sun Biomedical Laboratories, Inc., Blackwood NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981314 is the FDA 510(k) clearance record for VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE, a class II device, cleared for Sun Biomedical Laboratories, Inc. on under FDA product code DJR (Enzyme Immunoassay, Methadone). FDA records list 17 510(k) clearances for Sun Biomedical Laboratories, Inc., from to . As of , FDA records show no recalls naming K981314.

Clearance record

Decision date
Received
(147 days to decision)
Product code
DJR Enzyme Immunoassay, Methadone
Regulation
21 CFR 862.3620
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Sun Biomedical Laboratories, Inc. 604 Vpr Center, Blackwood NJ
510(k) summary
Statement
Third party review
No

Clearances, product code DJR

Trailing 12 months

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

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