510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K820085Substantially Equivalent

Dade Factor Assay Reference Plasma

American Dade, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820085 is the FDA 510(k) clearance record for DADE FACTOR ASSAY REFERENCE PLASMA, a class II device, cleared for American Dade on under FDA product code GGP (Test, Qualitative And Quantitative Factor Deficiency). FDA records list 149 510(k) clearances for American Dade, from to . As of , FDA records show no recalls naming K820085.

Clearance record

Decision date
Received
(42 days to decision)
Product code
GGP Test, Qualitative And Quantitative Factor Deficiency
Regulation
21 CFR 864.7290
Device class
Class II
Review panel
Hematology
Applicant
American Dade 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GGP

Trailing 12 months

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

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