510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040459Substantially Equivalent

Triage Profiler S.o.b. Controls and S.o.b. Calibration Verification Controls

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

K040459 is the FDA 510(k) clearance record for TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS, a class I device, cleared for Biosite Incorporated on under FDA product code JJY (Multi-Analyte Controls, All Kinds (Assayed)). FDA records list 46 510(k) clearances for Biosite Incorporated, from to . As of , FDA records show no recalls naming K040459.

Clearance record

Decision date
Received
(134 days to decision)
Product code
JJY Multi-Analyte Controls, All Kinds (Assayed)
Regulation
21 CFR 862.1660
Device class
Class I
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 JJY

Trailing 12 months

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

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