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11 devices found
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Manufacturer: Oxis Intl., Inc.
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Class
Innoflour Topiramate Reagent Set
Oxis Intl., Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K970510
Active
Cleared 12 May 1997
Active
510(k)
510(k)
II
Innofluor Theophylline Assay System
Oxis Intl., Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K955567
Active
Cleared 24 Jan 1996
Active
510(k)
510(k)
II
B-L Red(Tm) Discs
Oxis Intl., Inc.
·
,
United States
(FDA 510(k) applicant)
Class I
FDA 510(k)
K950346
Active
Cleared 5 May 1995
Active
510(k)
510(k)
I
Innofluor Gentamicin Assay System
Oxis Intl., Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K972331
Active
Cleared 1 Aug 1997
Active
510(k)
510(k)
II
2 variants
Innofluor Gentamicin Assay System
K955569
Innofluor Amikacin Assay System
Oxis Intl., Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K955570
Active
Cleared 9 Feb 1996
Active
510(k)
510(k)
II
Innofluor Topiramate Control Set
Oxis Intl., Inc.
·
,
United States
(FDA 510(k) applicant)
Class I
FDA 510(k)
K970517
Active
Cleared 12 May 1997
Active
510(k)
510(k)
I
Innofluor Phenytoin Assay System
Oxis Intl., Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K955562
Active
Cleared 24 Jan 1996
Active
510(k)
510(k)
II
Innoflour Calibrator Reagent Set
Oxis Intl., Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K970509
Active
Cleared 12 May 1997
Active
510(k)
510(k)
II
Innofluor Phenobarbital Assay System
Oxis Intl., Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K972330
Active
Cleared 14 Jul 1997
Active
510(k)
510(k)
II
Innofluor Quinidine Assay System
Oxis Intl., Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K955568
Active
Cleared 4 Apr 1996
Active
510(k)
510(k)
II
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