FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

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