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."
145–164 of 164
Search insights Median review: 55d Cleared: 100% Top manufacturer: Sigma Diagnostics, Inc. Lead specialty: Chemistry
Cleared Aug 26, 1986
BUN (RATE) REAGENT
K863196 · CDQ
Sigma Diagnostics, Inc.
Chemistry · 7d
Cleared Jul 01, 1986
CHOLESTEROL CALIBRATORS
K861314 · JIT
Sigma Diagnostics, Inc.
Chemistry · 84d
Cleared May 23, 1986
ALBUMIN (BCG) REAGENT
K861467 · CIX
Sigma Diagnostics, Inc.
Chemistry · 32d
Cleared Mar 28, 1986
NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM
K860138 · DDB
Sigma Diagnostics, Inc.
Immunology · 73d
Cleared Feb 19, 1986
ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040
K860453 · JJX
Sigma Diagnostics, Inc.
Chemistry · 14d
Cleared Jan 22, 1986
SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV
K854245 · KQN
Sigma Diagnostics, Inc.
Chemistry · 93d
Cleared Dec 04, 1985
CK(OPTIMIZED) REAGENT
K854501 · CGS
Sigma Diagnostics, Inc.
Chemistry · 22d
Cleared Nov 25, 1985
AST(OPTIMIZED) REAGENT
K854503 · CIT
Sigma Diagnostics, Inc.
Chemistry · 13d
Cleared Nov 25, 1985
ALT(OPTIMIZED) REAGENT
K854502 · CKA
Sigma Diagnostics, Inc.
Chemistry · 13d
Cleared Oct 28, 1985
SIGMA 610 FOR PROTEIN IN URINE & CSF
K853681 · CEK
Sigma Diagnostics, Inc.
Chemistry · 54d
Cleared Oct 22, 1985
GRAM STAIN KIT
K853896 · JTS
Sigma Diagnostics, Inc.
Pathology · 32d
Cleared Aug 19, 1985
URIC ACID REAGENT
K853357 · KNK
Sigma Diagnostics, Inc.
Chemistry · 7d
Cleared Jun 10, 1985
BUN(ENDPOINT) REAGENT
K852131 · CDQ
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Jun 10, 1985
GLUCOSE(TRINDER) REAGENT
K852130 · CGA
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Mar 20, 1985
BUN (RATE) REAGENT
K850923 · CDQ
Sigma Diagnostics, Inc.
Chemistry · 15d
Cleared Feb 12, 1985
Y-GLUTAMYLTRANSFERASE(Y-GT) REAGENT
K850319 · JQB
Sigma Diagnostics, Inc.
Chemistry · 15d
Cleared Dec 11, 1984
TRIGLYCERIDE CALIBRATOR
K844468 · JIT
Sigma Diagnostics, Inc.
Chemistry · 22d
Cleared Nov 09, 1984
TRIGLYCERIDE REAGENT
K844032 · CDT
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Jun 14, 1984
SIGMA PROCED. 245 ALKALINE PHOSPHATASE
K841918 · CJE
Sigma Diagnostics, Inc.
Chemistry · 36d
Cleared Jun 14, 1984
SIGMS PROCED. 228 UV LACTATE DEHYDRO
K841917 · CFJ
Sigma Diagnostics, Inc.
Chemistry · 36d