510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862669Substantially Equivalent

Activated Partial Thromboplastin Time Test

U. S. Diagnostics, Inc., San Luis Obispo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862669 is the FDA 510(k) clearance record for ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST, a class I device, cleared for U. S. Diagnostics, Inc. on under FDA product code GFD (Dermatome). FDA records list 22 510(k) clearances for U. S. Diagnostics, Inc., from to . As of , FDA records show no recalls naming K862669.

Clearance record

Decision date
Received
(81 days to decision)
Product code
GFD Dermatome
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
U. S. Diagnostics, Inc. P.O. Box 4522, San Luis Obispo CA
Third party review
No

Clearances, product code GFD

Trailing 12 months

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

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