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12 devices found
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Manufacturer: Wyntek Diagnostics, Inc.
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Device · Manufacturer · Authorizations
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Class
Osom Card Ii Hcg-Urine Test, Model 102
Wyntek Diagnostics, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K990578
Active
Cleared 9 Mar 1999
Active
510(k)
510(k)
II
Osom Mono Test 143
Wyntek Diagnostics, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K972231
Active
Cleared 26 Aug 1997
Active
510(k)
510(k)
II
Osom Strep A Test
Wyntek Diagnostics, Inc.
·
,
United States
(FDA 510(k) applicant)
Class I
FDA 510(k)
K961423
Active
Cleared 11 Oct 1996
Active
510(k)
510(k)
I
Osom Card Hcg-Urine Test
Wyntek Diagnostics, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K973879
Active
Cleared 4 Nov 1997
Active
510(k)
510(k)
II
Osom Ultra Strep A Test, Model 147
Wyntek Diagnostics, Inc.
·
,
United States
(FDA 510(k) applicant)
Class I
FDA 510(k)
K992658
Active
Cleared 18 Jan 2000
Active
510(k)
510(k)
I
Perfecta Pregnancy Test
Wyntek Diagnostics, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K965184
Active
Cleared 4 Feb 1997
Active
510(k)
510(k)
II
Osom Hcg-Urine Test Model 101
Wyntek Diagnostics, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K974159
Active
Cleared 24 Dec 1997
Active
510(k)
510(k)
II
Osom Pregnancy Test
Wyntek Diagnostics, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K954178
Active
Cleared 23 Oct 1995
Active
510(k)
510(k)
II
Wyntek Osom Hcg-Urine Test
Wyntek Diagnostics, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K953383
Active
Cleared 29 Aug 1995
Active
510(k)
510(k)
II
Osom Classic Hcg-Urine Test (115)
Wyntek Diagnostics, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K965227
Active
Cleared 4 Feb 1997
Active
510(k)
510(k)
II
Osom Card Pregnancy Test, Model 103
Wyntek Diagnostics, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K990576
Active
Cleared 9 Mar 1999
Active
510(k)
510(k)
II
Osom Hcg Combo Test
Wyntek Diagnostics, Inc.
·
,
United States
(FDA 510(k) applicant)
Class I
FDA 510(k)
K955141
Active
Cleared 6 Dec 1995
Active
510(k)
510(k)
I
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