510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K922646Substantially Equivalent

Reference Preparation for Proteins in Human Serum

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

K922646 is the FDA 510(k) clearance record for REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM, a class II device, cleared for Behring Diagnostics, Inc. on under FDA product code JIS (Calibrator, Primary). FDA records list 145 510(k) clearances for Behring Diagnostics, Inc., from to . As of , FDA records show no recalls naming K922646.

Clearance record

Decision date
Received
(387 days to decision)
Product code
JIS Calibrator, Primary
Regulation
21 CFR 862.1150
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Behring Diagnostics, Inc. 17 Chubb Way, Somerville NJ
510(k) summary
Summary
Third party review
No

Clearances, product code JIS

Trailing 12 months

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

FDA records show no clearances under product code JIS in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JIS, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260