510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K890633Substantially Equivalent

Enzygnost Platelet Factor 4 (Pf4) Kit

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

K890633 is the FDA 510(k) clearance record for ENZYGNOST PLATELET FACTOR 4 (PF4) KIT, a class II device, cleared for Behring Diagnostics, Inc. on under FDA product code LCO (Platelet Factor 4 Radioimmunoassay). FDA records list 145 510(k) clearances for Behring Diagnostics, Inc., from to . As of , FDA records show no recalls naming K890633.

Clearance record

Decision date
Received
(72 days to decision)
Product code
LCO Platelet Factor 4 Radioimmunoassay
Regulation
21 CFR 864.7695
Device class
Class II
Review panel
Hematology
Applicant
Behring Diagnostics, Inc. 17 Chubb Way, Somerville NJ
Third party review
No

Clearances, product code LCO

Trailing 12 months

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

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