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."
73–96 of 164
Search insights Median review: 55d Cleared: 100% Top manufacturer: Sigma Diagnostics, Inc. Lead specialty: Chemistry
Cleared Jul 13, 1994
THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS
K942192 · LER
Sigma Diagnostics, Inc.
Chemistry · 70d
Cleared Jul 13, 1994
DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET
K940569 · KXT
Sigma Diagnostics, Inc.
Chemistry · 155d
Cleared Jun 02, 1994
APOLIPOPROTIEN A-1 (APO A-1)
K932606 · JHN
Sigma Diagnostics, Inc.
Chemistry · 370d
Cleared Jun 02, 1994
APOLIPOPROTIEN B (APO B)
K932603 · JHN
Sigma Diagnostics, Inc.
Chemistry · 370d
Cleared May 17, 1994
LIPASE-PS ASSAY PROCEDURE NO. 805
K941085 · CHI
Sigma Diagnostics, Inc.
Chemistry · 70d
Cleared May 17, 1994
ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY
K935308 · JBQ
Sigma Diagnostics, Inc.
Hematology · 196d
Cleared Mar 15, 1994
FACTOR VIII DEFICIENT PLASMA
K935057 · GJT
Sigma Diagnostics, Inc.
Hematology · 145d
Cleared Mar 07, 1994
FACTOR
K935058 · GJT
Sigma Diagnostics, Inc.
Hematology · 137d
Cleared Mar 07, 1994
FACTOR VII DEFICIENT PLASMA
K935056 · GJT
Sigma Diagnostics, Inc.
Hematology · 137d
Cleared Mar 07, 1994
FACTOR X DEFICIENT PLASMA
K935054 · GJT
Sigma Diagnostics, Inc.
Hematology · 137d
Cleared Nov 16, 1993
AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812
K933425 · DKC
Sigma Diagnostics, Inc.
Chemistry · 126d
Cleared Nov 09, 1993
IRON/UIBC REAGENT
K932517 · JMO
Sigma Diagnostics, Inc.
Chemistry · 168d
Cleared Oct 18, 1993
TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
K932980 · CDX
Sigma Diagnostics, Inc.
Chemistry · 123d
Cleared Jun 16, 1993
ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III
K932067 · DKC
Sigma Diagnostics, Inc.
Toxicology · 48d
Cleared May 11, 1993
THROMBOPLATIN-M WITH CALCIUM
K930212 · GJS
Sigma Diagnostics, Inc.
Hematology · 116d
Cleared Mar 04, 1992
FIBRINOGEN CONTROL
K915462 · GIL
Sigma Diagnostics, Inc.
Hematology · 91d
Cleared Feb 18, 1992
MICROPROTEIN-PR
K915380 · CEK
Sigma Diagnostics, Inc.
Chemistry · 81d
Cleared Jan 27, 1992
DIGITOXIN FPIA REAGENT SET
K915465 · LFM
Sigma Diagnostics, Inc.
Toxicology · 56d
Cleared Jan 23, 1992
ACTIVATED PARTIAL THROMBOPLASTIN TIME
K915463 · GGW
Sigma Diagnostics, Inc.
Hematology · 50d
Cleared Jan 15, 1992
DIGITOXIN FPIA CALIBRATOR SET
K915464 · DLJ
Sigma Diagnostics, Inc.
Toxicology · 44d
Cleared Dec 27, 1991
SIGMA PROCEDURE NO. 333-UV
K914777 · DML
Sigma Diagnostics, Inc.
Toxicology · 65d
Cleared Oct 09, 1991
FIBRINOGEN DETERMINATION KIT
K913061 · GIS
Sigma Diagnostics, Inc.
Hematology · 91d
Cleared Sep 11, 1991
AMYLASE REAGENT (PROCEDURE 577)
K913858 · JFJ
Sigma Diagnostics, Inc.
Chemistry · 15d
Cleared Jul 24, 1991
HEPARIN ADSORBENT
K912061 · JPA
Sigma Diagnostics, Inc.
Hematology · 76d