510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K901333Substantially Equivalent

Beta-2 Microglobulin Eia

Serex, Inc., Tenafly NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901333 is the FDA 510(k) clearance record for BETA-2 MICROGLOBULIN EIA, a class II device, cleared for Serex, Inc. on under FDA product code JZG (System, Test, Beta-2-Microglobulin Immunological). FDA records list 2 510(k) clearances for Serex, Inc., from to . As of , FDA records show no recalls naming K901333.

Clearance record

Decision date
Received
(13 days to decision)
Product code
JZG System, Test, Beta-2-Microglobulin Immunological
Regulation
21 CFR 866.5630
Device class
Class II
Review panel
Immunology
Applicant
Serex, Inc. 38 Franklin St., Tenafly NJ
Third party review
No

Clearances, product code JZG

Trailing 12 months

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

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