510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011068Substantially Equivalent

Rhigene Ndna Test System for Imagetiter, Model Cl100l

Rhigene, Inc., Des Plaines IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011068 is the FDA 510(k) clearance record for RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L, a class II device, cleared for Rhigene, Inc. on under FDA product code KTL (Anti-Dna Indirect Immunofluorescent Solid Phase). FDA records list 15 510(k) clearances for Rhigene, Inc., from to . As of , FDA records show no recalls naming K011068.

Clearance record

Decision date
Received
(367 days to decision)
Product code
KTL Anti-Dna Indirect Immunofluorescent Solid Phase
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
Rhigene, Inc. 455 State St.,, Des Plaines IL
510(k) summary
Statement
Third party review
No

Clearances, product code KTL

Trailing 12 months

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

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