510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780012Substantially Equivalent

Antithrombin III Ria

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

K780012 is the FDA 510(k) clearance record for ANTITHROMBIN III RIA, a class II device, cleared for Ria Diagnostics on under FDA product code DDQ (Antigen, Antiserum, Control, Antithrombin Iii). FDA records list 7 510(k) clearances for Ria Diagnostics, from to . As of , FDA records show no recalls naming K780012.

Clearance record

Decision date
Received
(17 days to decision)
Product code
DDQ Antigen, Antiserum, Control, Antithrombin Iii
Regulation
21 CFR 864.7060
Device class
Class II
Review panel
Hematology
Applicant
Ria Diagnostics 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DDQ

Trailing 12 months

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

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