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."
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