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."
25–48 of 164
Search insights Median review: 55d Cleared: 100% Top manufacturer: Sigma Diagnostics, Inc. Lead specialty: Chemistry
Cleared Aug 18, 1998
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT
K982251 · CDO
Sigma Diagnostics, Inc.
Chemistry · 53d
Cleared Aug 05, 1998
SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT
K982236 · CDQ
Sigma Diagnostics, Inc.
Chemistry · 41d
Cleared Apr 29, 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL III
K981255 · GGN
Sigma Diagnostics, Inc.
Hematology · 23d
Cleared Apr 29, 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL II
K981254 · GGN
Sigma Diagnostics, Inc.
Hematology · 23d
Cleared Apr 29, 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL I
K981248 · GGN
Sigma Diagnostics, Inc.
Hematology · 23d
Cleared Apr 21, 1998
INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)
K980667 · CHH
Sigma Diagnostics, Inc.
Chemistry · 60d
Cleared Mar 20, 1998
INFINITY AST REAGENT (PROCEDURE NO. 51)
K980666 · CIT
Sigma Diagnostics, Inc.
Chemistry · 28d
Cleared Oct 31, 1997
ACCUCOLOR HIGH CALIBRATOR (A3089)
K973274 · GIZ
Sigma Diagnostics, Inc.
Hematology · 59d
Cleared Oct 20, 1997
CS-400 COAGULATION ANALYZER SYSTEM (A1208)
K972260 · JPA
Sigma Diagnostics, Inc.
Hematology · 125d
Cleared Oct 10, 1997
SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM
K972796 · GJS
Sigma Diagnostics, Inc.
Hematology · 74d
Cleared Oct 09, 1997
SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)
K971858 · KQJ
Sigma Diagnostics, Inc.
Hematology · 142d
Cleared Sep 22, 1997
SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT
K972743 · CGX
Sigma Diagnostics, Inc.
Chemistry · 61d
Cleared Jul 31, 1997
DIGOXIN DG-II FPIA REAGENT SET
K972794 · KXT
Sigma Diagnostics, Inc.
Toxicology · 55d
Cleared Jul 30, 1997
SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC...
K972132 · LEG
Sigma Diagnostics, Inc.
Toxicology · 54d
Cleared Jul 25, 1997
SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III
K972144 · JBQ
Sigma Diagnostics, Inc.
Hematology · 49d
Cleared Jul 22, 1997
EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)
K972041 · LBS
Sigma Diagnostics, Inc.
Chemistry · 50d
Cleared Jan 17, 1997
SIGMA DIAGNOSTICS GLUCOSE REAGENT
K963535 · CGA
Sigma Diagnostics, Inc.
Chemistry · 135d
Cleared Dec 16, 1996
SIGMA DIAGNOSTICS WASH CONCENTRATE
K963539 · JJE
Sigma Diagnostics, Inc.
Chemistry · 103d
Cleared Oct 30, 1996
SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2
K963543 · JIX
Sigma Diagnostics, Inc.
Chemistry · 56d
Cleared Oct 29, 1996
SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1
K963533 · JIX
Sigma Diagnostics, Inc.
Chemistry · 55d
Cleared Oct 24, 1996
SIGMA DIAGNOSTICS CO2 ACID REAGENT
K963541 · JFL
Sigma Diagnostics, Inc.
Chemistry · 50d
Cleared Oct 24, 1996
SIGMA DIAGNOSTICS BUN REAGENT
K963537 · LFP
Sigma Diagnostics, Inc.
Chemistry · 50d
Cleared Oct 11, 1996
SIGMA DIAGNOSTICS CO2ALKALINE BUFFER
K963538 · JFL
Sigma Diagnostics, Inc.
Chemistry · 37d
Cleared Oct 10, 1996
SIGMA DIAGNOSTICS CALICIUM REAGENT
K963536 · CJY
Sigma Diagnostics, Inc.
Chemistry · 37d