FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

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