510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915551Substantially Equivalent

Ortho Hsv Antigen Elisa Test

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

K915551 is the FDA 510(k) clearance record for ORTHO HSV ANTIGEN ELISA TEST, a class II device, cleared for Ortho Diagnostic Systems, Inc. on under FDA product code LGC (Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific). FDA records list 126 510(k) clearances for Ortho Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K915551.

Clearance record

Decision date
Received
(133 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
Ortho Diagnostic Systems, Inc. 1125 Mark Ave., Carpinteria CA
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