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13 devices found
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Manufacturer: Sure-Tech Diagnostic Associates, Inc.
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Device · Manufacturer · Authorizations
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Registry
Class
ST 201 Fetal Hemoglobin Control
Sure-Tech Diagnostic Associates, Inc.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
ST 201-B Fetal Hemoglobin Control
Sure-Tech Diagnostic Associates, Inc.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
ST 201-C Fetal Hemoglobin Control
Sure-Tech Diagnostic Associates, Inc.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Fetal Hemoglobin Kit - 100 test kit ST 101-A
Sure-Tech Diagnostic Associates, Inc.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Fetal Hemoglobin Test Kit - 300 test kit ST 101-C
Sure-Tech Diagnostic Associates, Inc.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Fetal Hemoglobin Kit - 200 test kit ST 101-B
Sure-Tech Diagnostic Associates, Inc.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Red Cell Fixing Solution - 120mL 101-10
Sure-Tech Diagnostic Associates, Inc.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Citrate Phosphate Buffer 120 mL 101-20
Sure-Tech Diagnostic Associates, Inc.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Hemoglobin Staining Solution 101-30
Sure-Tech Diagnostic Associates, Inc.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Citrate Phosphate Buffer 500 mL 101-20x500
Sure-Tech Diagnostic Associates, Inc.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Red Cell Fixing Solution - 500mL 101-10x500
Sure-Tech Diagnostic Associates, Inc.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Hemoglobin Staining Solution 500 mL 101-30x500
Sure-Tech Diagnostic Associates, Inc.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Fetal Hemoglobin
Sure-Tech Diagnostic Associates, Inc.
·
,
FDA registration: United States
Class II
FDA 510(k)
K892241
Active
Cleared 17 May 1989
Active
510(k)
510(k)
II
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