510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012701Substantially Equivalent

Ultegra System Rapid Platelet Function Assay - Asa (Rpfa-Asa)

Accumetrics, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012701 is the FDA 510(k) clearance record for ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA), a class II device, cleared for Accumetrics, Inc. on under FDA product code JOZ (System, Automated Platelet Aggregation). FDA records list 7 510(k) clearances for Accumetrics, Inc., from to . As of , FDA records show one recall naming K012701.

Clearance record

Decision date
Received
(302 days to decision)
Product code
JOZ System, Automated Platelet Aggregation
Regulation
21 CFR 864.5700
Device class
Class II
Review panel
Hematology
Applicant
Accumetrics, Inc. 3985 Sorrento Valley Blvd., San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code JOZ

Trailing 12 months

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

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