510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K895122Substantially Equivalent

Ciba Corning Magic Lite Chlamydia Immunoassay

Ciba Corning Diagnostics Corp., East Walpole MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895122 is the FDA 510(k) clearance record for CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY, a class I device, cleared for Ciba Corning Diagnostics Corp. on under FDA product code LJC (Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)). FDA records list 125 510(k) clearances for Ciba Corning Diagnostics Corp., from to . As of , FDA records show no recalls naming K895122.

Clearance record

Decision date
Received
(76 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
Ciba Corning Diagnostics Corp. 333 Coney St., East Walpole MA
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LJC, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260