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510k Database
Manufacturers
US
Datachem, Inc.
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Medical Device Manufacturer
·
US , Mchenry , IL
Datachem, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1981
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Datachem, Inc.
Chemistry
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 05, 1990
MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZER
K900788
·
CEM
Chemistry
·
135d
Cleared
Mar 09, 1984
APSARA ANALYZER
K834534
·
JJE
Chemistry
·
78d
Cleared
Feb 09, 1983
APSARA CLINICAL DIAG. & INFO. SYS
K823386
·
JJE
Chemistry
·
86d
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5
Chemistry
3
General Hospital
2