510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K071961Substantially Equivalent

Mesacup Models Bp180 and Bp230 Elisa Kits

Mbl International Corporation, Deer Field IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071961 is the FDA 510(k) clearance record for MESACUP MODELS BP180 AND BP230 ELISA KITS, a class II device, cleared for Mbl International Corporation on under FDA product code OEG (Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230). FDA's definition for product code OEG reads: "The device is intended as an aid in the diagnosis of bullous pemphigoid". FDA records list 2 510(k) clearances for Mbl International Corporation, from to . As of , FDA records show no recalls naming K071961.

Clearance record

Decision date
Received
(406 days to decision)
Product code
OEG Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
Mbl International Corporation P.O. Box 7007, Deer Field IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OEG

Trailing 12 months

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

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