510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920416Substantially Equivalent

Supplementary Reagents for Enzygnost/tmb

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

K920416 is the FDA 510(k) clearance record for SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB, a class I device, cleared for Behring Diagnostics, Inc. on under FDA product code LIB (Device, General Purpose, Microbiology, Diagnostic). FDA records list 145 510(k) clearances for Behring Diagnostics, Inc., from to . As of , FDA records show no recalls naming K920416.

Clearance record

Decision date
Received
(68 days to decision)
Product code
LIB Device, General Purpose, Microbiology, Diagnostic
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Behring Diagnostics, Inc. 17 Chubb Way, Somerville NJ
510(k) summary
Statement
Third party review
No

Clearances, product code LIB

Trailing 12 months

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

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