510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033383Substantially Equivalent

Triage Bnp Test for the Beckman Coulter Immunoassay Systems, Model Catalog #98200

Biosite Incorporated, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033383 is the FDA 510(k) clearance record for TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200, a class II device, cleared for Biosite Incorporated on under FDA product code NBC (Test, Natriuretic Peptide). FDA records list 46 510(k) clearances for Biosite Incorporated, from to . As of , FDA records show one recall naming K033383.

Clearance record

Decision date
Received
(61 days to decision)
Product code
NBC Test, Natriuretic Peptide
Regulation
21 CFR 862.1117
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Biosite Incorporated 11030 Roselle St., San Diego CA
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