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."
97–120 of 164
Search insights Median review: 55d Cleared: 100% Top manufacturer: Sigma Diagnostics, Inc. Lead specialty: Chemistry
Cleared Apr 29, 1991
HEPARIN CONTROLS, HIGH AND LOW
K910741 · KFF
Sigma Diagnostics, Inc.
Hematology · 67d
Cleared Apr 03, 1991
FLOW CYTOMETRY FITC/PE COMPENSATION KIT
K910255 · JIW
Sigma Diagnostics, Inc.
Hematology · 71d
Cleared Apr 03, 1990
SIGMA PROCEDURE NO. 735
K897147 · KHP
Sigma Diagnostics, Inc.
Chemistry · 98d
Cleared Oct 04, 1989
CALCIUM (ARSENAZO III) REAGENT
K894204 · CJY
Sigma Diagnostics, Inc.
Chemistry · 107d
Cleared Sep 07, 1989
TRIGLYCERIDE (GPO) TRINDER REAGENT
K894063 · JGY
Sigma Diagnostics, Inc.
Chemistry · 91d
Cleared Mar 28, 1989
SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE
K884184 · LCP
Sigma Diagnostics, Inc.
Chemistry · 175d
Cleared Feb 24, 1989
ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET
K890674 · IAF
Sigma Diagnostics, Inc.
Pathology · 15d
Cleared Feb 24, 1989
WRIGHT-GLEMSA STAIN
K890673 · IAF
Sigma Diagnostics, Inc.
Pathology · 15d
Cleared Feb 17, 1989
HDL CHOLESTEROL REAGENT (PTA/MGCL2)
K890023 · LBR
Sigma Diagnostics, Inc.
Chemistry · 44d
Cleared Apr 21, 1988
FUNGI HISTOLOGY CONTROL SLIDES
K881112 · LJG
Sigma Diagnostics, Inc.
Microbiology · 37d
Cleared Apr 21, 1988
SPIROCHETES HISTOLOGY CONTROL SLIDES
K881109 · LJG
Sigma Diagnostics, Inc.
Microbiology · 37d
Cleared Apr 21, 1988
ACID FAST BACILLI HISTOLOGY CONTROL SLIDES
K881106 · LJG
Sigma Diagnostics, Inc.
Microbiology · 37d
Cleared Apr 21, 1988
FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527
K880038 · KHG
Sigma Diagnostics, Inc.
Hematology · 107d
Cleared Apr 12, 1988
LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDES
K881110 · LJG
Sigma Diagnostics, Inc.
Microbiology · 28d
Cleared Apr 12, 1988
PNEUMOCYSTIS CARINII HISTOLOGY CONTROL SLIDES
K881108 · LJG
Sigma Diagnostics, Inc.
Microbiology · 28d
Cleared Mar 30, 1988
INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL
K881111 · LJG
Sigma Diagnostics, Inc.
Microbiology · 15d
Cleared Mar 30, 1988
INTRACELLULAR AMYLOID HISTOLOGY CONTROL SLIDES
K881107 · LJG
Sigma Diagnostics, Inc.
Microbiology · 15d
Cleared Mar 15, 1988
CO2 REAGENT
K880268 · KHS
Sigma Diagnostics, Inc.
Chemistry · 54d
Cleared Feb 24, 1988
AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665
K880039 · JJX
Sigma Diagnostics, Inc.
Chemistry · 50d
Cleared Feb 09, 1988
RETICULOCYTE STAIN
K875310 · KFC
Sigma Diagnostics, Inc.
Pathology · 42d
Cleared Nov 04, 1987
NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)
K874115 · LKJ
Sigma Diagnostics, Inc.
Immunology · 26d
Cleared Oct 20, 1987
BILE ACIDS CONTROLS
K873342 · JJX
Sigma Diagnostics, Inc.
Chemistry · 62d
Cleared Oct 02, 1987
CREATININE REAGENT
K873365 · CGX
Sigma Diagnostics, Inc.
Chemistry · 42d
Cleared Aug 26, 1987
BILE ACIDS REAGENT
K872296 · KWW
Sigma Diagnostics, Inc.
Chemistry · 71d