510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K915463Substantially Equivalent

Activated Partial Thromboplastin Time

Sigma Diagnostics, Inc., St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915463 is the FDA 510(k) clearance record for ACTIVATED PARTIAL THROMBOPLASTIN TIME, a class II device, cleared for Sigma Diagnostics, Inc. on under FDA product code GGW (Test, Time, Partial Thromboplastin). FDA records list 164 510(k) clearances for Sigma Diagnostics, Inc., from to . As of , FDA records show no recalls naming K915463.

Clearance record

Decision date
Received
(50 days to decision)
Product code
GGW Test, Time, Partial Thromboplastin
Regulation
21 CFR 864.7925
Device class
Class II
Review panel
Hematology
Applicant
Sigma Diagnostics, Inc. 545 S. Ewing Ave., St. Louis MO
510(k) summary
Statement
Third party review
No

Clearances, product code GGW

Trailing 12 months
1 clearance under product code GGW in the twelve months to November 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GGW, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260