510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093784Substantially Equivalent

Athena Multi-Lyte Torch Igg Plus Test System

Zeus Scientific LLC, Raritan NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093784 is the FDA 510(k) clearance record for ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM, a class II device, cleared for Zeus Scientific, Inc. on under FDA product code OPM (Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2). FDA's definition for product code OPM reads: "The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to Toxoplasma gondii (T.gondii), Rubella, Cytomegalovirus (CMV) and Herpes Simplex Virus 1 & 2 (HSV 1 and HSV 2) in human serum...". FDA records list 141 510(k) clearances for Zeus Scientific, Inc., from to . As of , FDA records show no recalls naming K093784.

Clearance record

Decision date
Received
(219 days to decision)
Product code
OPM Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2
Regulation
21 CFR 866.3510
Device class
Class II
Review panel
Microbiology
Applicant
Zeus Scientific, Inc. P.O.Box 38, Raritan NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OPM

Trailing 12 months

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

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