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."
121–144 of 164
Search insights Median review: 55d Cleared: 100% Top manufacturer: Sigma Diagnostics, Inc. Lead specialty: Chemistry
Cleared Aug 21, 1987
BILE ACIDS CALIBRATOR
K872451 · JIT
Sigma Diagnostics, Inc.
Chemistry · 59d
Cleared Aug 13, 1987
PROCEDURE NO. 552/553 BILIRUBIN, TOTAL AND DIRECT
K872197 · CIG
Sigma Diagnostics, Inc.
Chemistry · 66d
Cleared Jul 16, 1987
CHOLESTEROL REAGENT
K872295 · CHH
Sigma Diagnostics, Inc.
Chemistry · 30d
Cleared Jul 07, 1987
DIGOXIN FPIA CONTROLS
K872347 · LAS
Sigma Diagnostics, Inc.
Toxicology · 20d
Cleared Jul 01, 1987
PHENYTOIN FPIA CONTROLS
K871567 · LAS
Sigma Diagnostics, Inc.
Chemistry · 70d
Cleared Jun 12, 1987
SIGMA'S CALCIUM PROCEDURE NO. 587
K871152 · CIC
Sigma Diagnostics, Inc.
Chemistry · 81d
Cleared Jun 11, 1987
PHENYTOIN FPIA CALIBRATORS
K871423 · DLJ
Sigma Diagnostics, Inc.
Toxicology · 63d
Cleared Jun 01, 1987
THEOPHYLLINE FPIA CALIBRATORS
K871394 · DLJ
Sigma Diagnostics, Inc.
Toxicology · 55d
Cleared Apr 29, 1987
NEW FUCHSIN SOLUTION
K871545 · IDF
Sigma Diagnostics, Inc.
Pathology · 15d
Cleared Apr 29, 1987
METHYL GREEN SOLUTION
K871544 · HZA
Sigma Diagnostics, Inc.
Pathology · 15d
Cleared Apr 01, 1987
DIGOXIN FPIA REAGENT SET
K870951 · KXT
Sigma Diagnostics, Inc.
Toxicology · 22d
Cleared Mar 31, 1987
PHENYTOIN FPIA REAGENT SET
K870953 · DIP
Sigma Diagnostics, Inc.
Toxicology · 21d
Cleared Mar 31, 1987
THEOPHYLLINE FPIA REAGENT SET
K870952 · KLS
Sigma Diagnostics, Inc.
Toxicology · 21d
Cleared Feb 20, 1987
TRIGLYCERIDE (GPO-TRINDER) REAGENT
K870012 · CDT
Sigma Diagnostics, Inc.
Chemistry · 49d
Cleared Dec 31, 1986
CHLORIDE REAGENT
K864713 · CHJ
Sigma Diagnostics, Inc.
Chemistry · 28d
Cleared Dec 22, 1986
TISSUE GRAM STAIN
K864531 · ICF
Sigma Diagnostics, Inc.
Pathology · 35d
Cleared Nov 24, 1986
MULTI-ANALYTE LIN-TROL
K863751 · JJY
Sigma Diagnostics, Inc.
Chemistry · 60d
Cleared Nov 13, 1986
RAPID ACID FAST STAIN
K864033 · KJY
Sigma Diagnostics, Inc.
Pathology · 29d
Cleared Oct 29, 1986
ELASTIC STAIN
K864074 · IAC
Sigma Diagnostics, Inc.
Pathology · 9d
Cleared Oct 16, 1986
ACID PHOSPHATASE (ACP) REAGENT
K863851 · CKB
Sigma Diagnostics, Inc.
Chemistry · 14d
Cleared Sep 17, 1986
ALBUMIN (BCP)
K863226 · CJW
Sigma Diagnostics, Inc.
Chemistry · 27d
Cleared Sep 17, 1986
CHOLINESTERASE (BTC) REAGENT
K863203 · DIH
Sigma Diagnostics, Inc.
Chemistry · 29d
Cleared Sep 16, 1986
CHOLINESTERASE (PTC) REAGENT
K863202 · DIH
Sigma Diagnostics, Inc.
Chemistry · 28d
Cleared Aug 29, 1986
ALP (OPT) REAGENT
K862905 · CJE
Sigma Diagnostics, Inc.
Chemistry · 29d