Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

164 results for "Sigma Diagnostics, Inc."
1–24 of 164
Search insights Median review: 55d Cleared: 100% Top manufacturer: Sigma Diagnostics, Inc. Lead specialty: Chemistry
Cleared Aug 30, 2002
AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU,...
K021162 · JPA
Sigma Diagnostics, Inc.
Hematology · 141d
Cleared Feb 06, 2002
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
K020109 · GGC
Sigma Diagnostics, Inc.
Hematology · 26d
Cleared Dec 26, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
K013549 · DAP
Sigma Diagnostics, Inc.
Hematology · 63d
Cleared Nov 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
K013545 · DAP
Sigma Diagnostics, Inc.
Hematology · 22d
Cleared Nov 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
K013544 · DAP
Sigma Diagnostics, Inc.
Hematology · 22d
Cleared Oct 26, 2001
INFINITY HBA KIT, MODELS 537-A, 537-B
K012410 · LCP
Sigma Diagnostics, Inc.
Hematology · 88d
Cleared Mar 30, 2001
SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
K010652 · JIX
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Mar 22, 2001
THROMBOMAX-HS WITH CALCIUM, MODEL T6540
K010158 · GGO
Sigma Diagnostics, Inc.
Hematology · 64d
Cleared Mar 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
K003267 · DAP
Sigma Diagnostics, Inc.
Hematology · 148d
Cleared Mar 01, 2001
SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
K003329 · GGC
Sigma Diagnostics, Inc.
Hematology · 128d
Cleared Mar 01, 2001
ACCUCLOT CONTROL I, MODEL A4089
K003328 · GIZ
Sigma Diagnostics, Inc.
Hematology · 128d
Cleared Aug 10, 2000
SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P,...
K001403 · CFR
Sigma Diagnostics, Inc.
Chemistry · 99d
Cleared Jul 03, 2000
EZ LDL CHOLESTEROL TEST SYSTEM
K993741 · MRR
Sigma Diagnostics, Inc.
Chemistry · 242d
Cleared Jun 26, 2000
INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)
K001569 · JFJ
Sigma Diagnostics, Inc.
Chemistry · 38d
Cleared Apr 07, 2000
ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
K000528 · GIR
Sigma Diagnostics, Inc.
Hematology · 50d
Cleared Apr 07, 2000
ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094
K000527 · GIR
Sigma Diagnostics, Inc.
Hematology · 50d
Cleared Dec 06, 1999
SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334
K992712 · GFO
Sigma Diagnostics, Inc.
Hematology · 117d
Cleared Dec 06, 1999
SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
K992711 · GFO
Sigma Diagnostics, Inc.
Hematology · 117d
Cleared Sep 28, 1999
SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS...
K992801 · CIT
Sigma Diagnostics, Inc.
Chemistry · 40d
Cleared Sep 28, 1999
SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P,...
K992800 · CDQ
Sigma Diagnostics, Inc.
Chemistry · 40d
Cleared Sep 28, 1999
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P,...
K992798 · CDO
Sigma Diagnostics, Inc.
Chemistry · 40d
Cleared Sep 13, 1999
SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P,...
K992803 · CHH
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Feb 11, 1999
INFINITY GLUCOSE REAGENT
K984574 · CFR
Sigma Diagnostics, Inc.
Chemistry · 50d
Cleared Oct 15, 1998
ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589
K982209 · GJA
Sigma Diagnostics, Inc.
Hematology · 114d