510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903132Substantially Equivalent

Ortho Chlamydia Antigen Elisa/elisa Cult Extra Buf

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

K903132 is the FDA 510(k) clearance record for ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF, a class I device, cleared for Ortho Diagnostic Systems, Inc. on under FDA product code LJC (Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)). FDA records list 126 510(k) clearances for Ortho Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K903132.

Clearance record

Decision date
Received
(157 days to decision)
Product code
LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
Regulation
21 CFR 866.3120
Device class
Class I
Review panel
Microbiology
Applicant
Ortho Diagnostic Systems, Inc. 1001 U.S. Hwy. 202, Raritan NJ
Third party review
No

Clearances, product code LJC

Trailing 12 months

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

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