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."
49–72 of 164
Search insights Median review: 55d Cleared: 100% Top manufacturer: Sigma Diagnostics, Inc. Lead specialty: Chemistry
Cleared Sep 30, 1996
SIGMA DIAGNOSTICS CREATININE REAGENT KIT
K963534 · CGX
Sigma Diagnostics, Inc.
Chemistry · 26d
Cleared Sep 27, 1996
SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT
K963542 · JGS
Sigma Diagnostics, Inc.
Chemistry · 23d
Cleared Sep 27, 1996
SIGMA DIAGNOSTICS ELECTROLYTE BUFFER
K963540 · JFL
Sigma Diagnostics, Inc.
Chemistry · 23d
Cleared Sep 10, 1996
KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)
K960875 · JPA
Sigma Diagnostics, Inc.
Hematology · 190d
Cleared Mar 13, 1996
AMAX CS-190 COAGULATION ANALYZER SYSTEM
K955720 · JPA
Sigma Diagnostics, Inc.
Hematology · 86d
Cleared Mar 12, 1996
KC 1A COAGULATION ANALYZER/SET
K955724 · JPA
Sigma Diagnostics, Inc.
Hematology · 85d
Cleared Mar 11, 1996
KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM
K955735 · JPA
Sigma Diagnostics, Inc.
Hematology · 84d
Cleared Feb 28, 1996
ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245
K954840 · CJE
Sigma Diagnostics, Inc.
Chemistry · 131d
Cleared Feb 16, 1996
VANCOMYCIN FPIA REAGENT SET
K955716 · LEH
Sigma Diagnostics, Inc.
Toxicology · 63d
Cleared Jan 24, 1996
TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS
K952557 · CDP
Sigma Diagnostics, Inc.
Chemistry · 236d
Cleared Jan 05, 1996
ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV
K954839 · CIT
Sigma Diagnostics, Inc.
Chemistry · 77d
Cleared Aug 11, 1995
ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247
K951584 · CJE
Sigma Diagnostics, Inc.
Chemistry · 127d
Cleared Jun 29, 1995
GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A
K933934 · JBF
Sigma Diagnostics, Inc.
Hematology · 687d
Cleared May 08, 1995
GLUCOSE (HK) REAGENT (PROCEDURE NO.16)
K945908 · CFR
Sigma Diagnostics, Inc.
Chemistry · 157d
Cleared Mar 21, 1995
PRIMIDONE FPIA REAGENT SET AND CALIBRATORS
K950028 · LFT
Sigma Diagnostics, Inc.
Toxicology · 76d
Cleared Jan 20, 1995
IGM RF EIA
K942908 · DHR
Sigma Diagnostics, Inc.
Immunology · 213d
Cleared Dec 02, 1994
ANTI DS-DNA
K943291 · LLL
Sigma Diagnostics, Inc.
Immunology · 147d
Cleared Nov 17, 1994
GENTAMICIN FPIA REAGENT SET AND CALIBRATORS
K943550 · LCQ
Sigma Diagnostics, Inc.
Toxicology · 119d
Cleared Nov 10, 1994
TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR
K944371 · LFW
Sigma Diagnostics, Inc.
Chemistry · 64d
Cleared Nov 10, 1994
FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE
K944063 · LGI
Sigma Diagnostics, Inc.
Chemistry · 83d
Cleared Nov 10, 1994
VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS
K943866 · LEG
Sigma Diagnostics, Inc.
Chemistry · 94d
Cleared Oct 27, 1994
PHENYTOIN FPIA REAGENT SET AND CALIBRATORS
K943313 · LGR
Sigma Diagnostics, Inc.
Toxicology · 108d
Cleared Jul 20, 1994
GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419
K935984 · JQB
Sigma Diagnostics, Inc.
Chemistry · 218d
Cleared Jul 19, 1994
ACT CONTROL SET
K940840 · JPA
Sigma Diagnostics, Inc.
Hematology · 146d