510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K924395Substantially Equivalent

Neothromitin(r)

Behring Diagnostics, Inc., Somerville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924395 is the FDA 510(k) clearance record for NEOTHROMITIN(R), a class I device, cleared for Behring Diagnostics, Inc. on under FDA product code GPO (Antigen, Cf, Typhus Fever Group). FDA records list 145 510(k) clearances for Behring Diagnostics, Inc., from to . As of , FDA records show no recalls naming K924395.

Clearance record

Decision date
Received
(92 days to decision)
Product code
GPO Antigen, Cf, Typhus Fever Group
Regulation
21 CFR 866.3500
Device class
Class I
Review panel
Microbiology
Applicant
Behring Diagnostics, Inc. 17 Chubb Way, Somerville NJ
510(k) summary
Summary
Third party review
No

Clearances, product code GPO

Trailing 12 months

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

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