Sigma Diagnostics, Inc. - FDA 510(k) Cleared Devices
164
Total
164
Cleared
0
Denied
86 devices
Cleared
Mar 15, 1988
CO2 REAGENT
Chemistry
54d
Cleared
Feb 24, 1988
AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665
Chemistry
50d
Cleared
Oct 20, 1987
BILE ACIDS CONTROLS
Chemistry
62d
Cleared
Oct 02, 1987
CREATININE REAGENT
Chemistry
42d
Cleared
Aug 26, 1987
BILE ACIDS REAGENT
Chemistry
71d
Cleared
Aug 21, 1987
BILE ACIDS CALIBRATOR
Chemistry
59d
Cleared
Aug 13, 1987
PROCEDURE NO. 552/553 BILIRUBIN, TOTAL AND DIRECT
Chemistry
66d
Cleared
Jul 16, 1987
CHOLESTEROL REAGENT
Chemistry
30d
Cleared
Jul 01, 1987
PHENYTOIN FPIA CONTROLS
Chemistry
70d
Cleared
Jun 12, 1987
SIGMA'S CALCIUM PROCEDURE NO. 587
Chemistry
81d
Cleared
Feb 20, 1987
TRIGLYCERIDE (GPO-TRINDER) REAGENT
Chemistry
49d
Cleared
Dec 31, 1986
CHLORIDE REAGENT
Chemistry
28d
Cleared
Nov 24, 1986
MULTI-ANALYTE LIN-TROL
Chemistry
60d
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
Feb 19, 1986
ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040
Chemistry
14d
Cleared
Jan 22, 1986
SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV
Chemistry
93d
Cleared
Dec 04, 1985
CK(OPTIMIZED) REAGENT
Chemistry
22d
Cleared
Nov 25, 1985
ALT(OPTIMIZED) REAGENT
Chemistry
13d
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