510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000336Substantially Equivalent

Rhigene Dsg-1 & Dsg-3 Elisa Test System, Model 7680 E

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

K000336 is the FDA 510(k) clearance record for RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E, a class II device, cleared for Rhigene, Inc. on under FDA product code NBO (Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)). FDA records list 15 510(k) clearances for Rhigene, Inc., from to . As of , FDA records show no recalls naming K000336.

Clearance record

Decision date
Received
(127 days to decision)
Product code
NBO Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)
Regulation
21 CFR 866.5660
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 NBO

Trailing 12 months

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

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