510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K023433Substantially Equivalent

Varelisa Cardiolipin Antibodies Screen, Models 15848 and 15896

Pharmacia Diagnostics GmbH & Co. KG, Freiburg, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023433 is the FDA 510(k) clearance record for VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896, a class II device, cleared for Pharmacia Diagnostics GmbH & Co. KG on under FDA product code MID (System, Test, Anticardiolipin Immunological). FDA records list one 510(k) clearance for Pharmacia Diagnostics GmbH & Co. KG. As of , FDA records show no recalls naming K023433.

Clearance record

Decision date
Received
(29 days to decision)
Product code
MID System, Test, Anticardiolipin Immunological
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
Pharmacia Diagnostics GmbH & Co. KG Munzingerstrasse 7, Freiburg, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MID

Trailing 12 months

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

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