510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K050590Substantially Equivalent

Enzy-Well Syphilis Igg, Model 91106

Diesse Diagnostica Senese S.P.A, Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050590 is the FDA 510(k) clearance record for ENZY-WELL SYPHILIS IGG, MODEL 91106, a class II device, cleared for Diesse Diagnostica Senese S.P.A. on under FDA product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum). FDA records list 2 510(k) clearances for Diesse Diagnostica Senese S.P.A., from to . As of , FDA records show no recalls naming K050590.

Clearance record

Decision date
Received
(520 days to decision)
Product code
LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Regulation
21 CFR 866.3830
Device class
Class II
Review panel
Microbiology
Applicant
Diesse Diagnostica Senese S.P.A. 555 NE 34th St. #1905, Miami FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LIP

Trailing 12 months

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

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