Sandare Chemical Co., Inc. - FDA 510(k) Cleared Devices
Recent clearances: EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST, SANDARE GLYCOHEMOGLOBIN PROCEDURE, SANDARE BCG ALBUMIN PROCEDURE
23
Total
23
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sandare Chemical Co., Inc. Chemistry ✕
15 devices
Cleared
Mar 17, 1986
SANDARE BCG ALBUMIN PROCEDURE
Chemistry
20d
Cleared
May 07, 1985
SANDARE IRON-BINDING CAPACITY PROCEDURE
Chemistry
28d
Cleared
Apr 30, 1985
SANDARE IRON PROCEDURE
Chemistry
21d
Cleared
Dec 10, 1984
SANDARE ALKALINE PHOSPHATASE PROCEDURE
Chemistry
20d
Cleared
Aug 17, 1984
SANDARE ACID PHOSPHATASE PROCEDURE
Chemistry
38d
Cleared
Jan 13, 1984
TRI-LEVEL BILIRUBIN CONTROLS
Chemistry
60d
Cleared
Nov 07, 1983
TOTAL & DIRECT BILIRUBIN PROCEDURES
Chemistry
69d
Cleared
Sep 12, 1983
ALBUMIN PROCEDURE BCP
Chemistry
39d
Cleared
Aug 24, 1983
SANDARE CALCIUM PROCEDURE
Chemistry
49d
Cleared
Aug 16, 1983
TOTAL PROTEIN PROCEDURE
Chemistry
41d
Cleared
Oct 02, 1981
SANDARE FAST 340 PHOSPHORUS PROCEDURE
Chemistry
11d
Cleared
Sep 01, 1981
SANDARE URIC ACID PROCEDURE
Chemistry
15d
Cleared
Mar 04, 1981
SANDARE NITROPRUSSIDE TEST PROCEDURE
Chemistry
7d
Cleared
Mar 05, 1980
SANDARE FAST 340 PHOSPHOROUS PROCEDURE
Chemistry
23d
Cleared
Jan 11, 1980
SANDARE CHLORIDE PROCEDURE
Chemistry
35d