Sigma Diagnostics, Inc. - FDA 510(k) Cleared Devices
164
Total
164
Cleared
0
Denied
164 devices
Cleared
Jun 12, 1987
SIGMA'S CALCIUM PROCEDURE NO. 587
Chemistry
81d
Cleared
Jun 11, 1987
PHENYTOIN FPIA CALIBRATORS
Toxicology
63d
Cleared
Jun 01, 1987
THEOPHYLLINE FPIA CALIBRATORS
Toxicology
55d
Cleared
Apr 29, 1987
METHYL GREEN SOLUTION
Pathology
15d
Cleared
Apr 29, 1987
NEW FUCHSIN SOLUTION
Pathology
15d
Cleared
Apr 01, 1987
DIGOXIN FPIA REAGENT SET
Toxicology
22d
Cleared
Mar 31, 1987
THEOPHYLLINE FPIA REAGENT SET
Toxicology
21d
Cleared
Mar 31, 1987
PHENYTOIN FPIA REAGENT SET
Toxicology
21d
Cleared
Feb 20, 1987
TRIGLYCERIDE (GPO-TRINDER) REAGENT
Chemistry
49d
Cleared
Dec 31, 1986
CHLORIDE REAGENT
Chemistry
28d
Cleared
Dec 22, 1986
TISSUE GRAM STAIN
Pathology
35d
Cleared
Nov 24, 1986
MULTI-ANALYTE LIN-TROL
Chemistry
60d
Cleared
Nov 13, 1986
RAPID ACID FAST STAIN
Pathology
29d
Cleared
Oct 29, 1986
ELASTIC STAIN
Pathology
9d
Cleared
Oct 16, 1986
ACID PHOSPHATASE (ACP) REAGENT
Chemistry
14d
Cleared
Sep 17, 1986
CHOLINESTERASE (BTC) REAGENT
Chemistry
29d
Cleared
Sep 17, 1986
ALBUMIN (BCP)
Chemistry
27d
Cleared
Sep 16, 1986
CHOLINESTERASE (PTC) REAGENT
Chemistry
28d
Cleared
Aug 29, 1986
ALP (OPT) REAGENT
Chemistry
29d
Cleared
Aug 26, 1986
BUN (RATE) REAGENT
Chemistry
7d
Cleared
Jul 01, 1986
CHOLESTEROL CALIBRATORS
Chemistry
84d
Cleared
May 23, 1986
ALBUMIN (BCG) REAGENT
Chemistry
32d
Cleared
Mar 28, 1986
NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM
Immunology
73d
Cleared
Feb 19, 1986
ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040
Chemistry
14d
Cleared
Jan 22, 1986
SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV
Chemistry
93d
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