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31 devices found
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Manufacturer: Dade Intl., Inc.
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Class
Paramax Triglycerid Reagent
Dade Intl., Inc.
·
,
United States
(FDA 510(k) applicant)
Class I
FDA 510(k)
K964346
Active
Cleared 28 Mar 1997
Active
510(k)
510(k)
I
Paramax Alanine Aminotransferase (Gpt) Reagent
Dade Intl., Inc.
·
,
United States
(FDA 510(k) applicant)
Class I
FDA 510(k)
K951332
Active
Cleared 19 Jun 1995
Active
510(k)
510(k)
I
Sysmex Ca-6000
Dade Intl., Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K964139
Active
Cleared 6 Feb 1997
Active
510(k)
510(k)
II
Stratus Ck-Mb Dendrimer Fluorometric Enzyme Immunoassay & Stratus Ck-Mb Dendrimer High Sample Diluent
Dade Intl., Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K952250
Active
Cleared 17 Jul 1995
Active
510(k)
510(k)
II
Dade Tru-Liquid Bilirubin Control
Dade Intl., Inc.
·
,
United States
(FDA 510(k) applicant)
Class I
FDA 510(k)
K972287
Active
Cleared 7 Jul 1997
Active
510(k)
510(k)
I
Dried Gram-Negative Mic/Combo Panels
Dade Intl., Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K970676
Active
Cleared 2 May 1997
Active
510(k)
510(k)
II
Dade Tru-Liquid Cardiac Control
Dade Intl., Inc.
·
,
United States
(FDA 510(k) applicant)
Class I
FDA 510(k)
K973974
Active
Cleared 6 Nov 1997
Active
510(k)
510(k)
I
Dade Stratus Troponin-I Control
Dade Intl., Inc.
·
,
United States
(FDA 510(k) applicant)
Class I
FDA 510(k)
K951888
Active
Cleared 13 Jul 1995
Active
510(k)
510(k)
I
Vancomycin Flex Reagent Cartridge
Dade Intl., Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K963267
Active
Cleared 13 Sep 1996
Active
510(k)
510(k)
II
Carbamazepine Flex Reagent Cartridge
Dade Intl., Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K962820
Active
Cleared 13 Sep 1996
Active
510(k)
510(k)
II
Microscan Rapid Fluorogenic Panels
Dade Intl., Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA PMA
P870049
Active
Approved 24 Feb 1988
Active
PMA
PMA
II
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