510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961784Substantially Equivalent

Copalis One Immunoassay System/toxoplasma Gondii/rubella/cmv Total Antibody Assays

Sienna Biotech, Inc., Columbia MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961784 is the FDA 510(k) clearance record for COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS, a class II device, cleared for Sienna Biotech, Inc. on under FDA product code LQN (Latex Agglutination Assay, Rubella). FDA records list 3 510(k) clearances for Sienna Biotech, Inc., from to . As of , FDA records show no recalls naming K961784.

Clearance record

Decision date
Received
(182 days to decision)
Product code
LQN Latex Agglutination Assay, Rubella
Regulation
21 CFR 866.3510
Device class
Class II
Review panel
Microbiology
Applicant
Sienna Biotech, Inc. 9115 Guilford Rd., Suite 180, Columbia MD
510(k) summary
Summary
Third party review
No

Clearances, product code LQN

Trailing 12 months

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

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