510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K984346Substantially Equivalent

Premier Type Specific Hsv-2 Igg Elisa Test

Meridian Diagnostics, Inc., Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984346 is the FDA 510(k) clearance record for PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST, a class II device, cleared for Meridian Diagnostics, Inc. on under FDA product code LGC (Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific). FDA records list 92 510(k) clearances for Meridian Diagnostics, Inc., from to . As of , FDA records show no recalls naming K984346.

Clearance record

Decision date
Received
(203 days to decision)
Product code
LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Regulation
21 CFR 866.3305
Device class
Class II
Review panel
Microbiology
Applicant
Meridian Diagnostics, Inc. 3471 River Hills Dr., Cincinnati OH
510(k) summary
Summary
Third party review
No

Clearances, product code LGC

Trailing 12 months

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

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