510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013544Substantially Equivalent

Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096

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

K013544 is the FDA 510(k) clearance record for SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096, a class II device, cleared for Sigma Diagnostics, Inc. on under FDA product code DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control). FDA records list 164 510(k) clearances for Sigma Diagnostics, Inc., from to . As of , FDA records show no recalls naming K013544.

Clearance record

Decision date
Received
(22 days to decision)
Product code
DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Regulation
21 CFR 864.7320
Device class
Class II
Review panel
Hematology
Applicant
Sigma Diagnostics, Inc. 545 S. Ewing Ave., St. Louis MO
510(k) summary
Summary
Third party review
No

Clearances, product code DAP

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