510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060964Substantially Equivalent

Architect Bnp Assay, Model 8K28

Fujirebio Diagnostics, Inc., Malvern PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060964 is the FDA 510(k) clearance record for ARCHITECT BNP ASSAY, MODEL 8K28, a class II device, cleared for Fujirebio Diagnostics,Inc. on under FDA product code NBC (Test, Natriuretic Peptide). FDA records list 45 510(k) clearances for Fujirebio Diagnostics,Inc., from to . As of , FDA records show 2 recalls naming K060964.

Clearance record

Decision date
Received
(48 days to decision)
Product code
NBC Test, Natriuretic Peptide
Regulation
21 CFR 862.1117
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Fujirebio Diagnostics,Inc. 201 Great Valley Pkwy., Malvern PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NBC

Trailing 12 months
3 clearances under product code NBC in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NBC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260