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535
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521
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496
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489
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431
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406
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400
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Manufacturers
US
Euro-Diagnostics BV
Medical Device Manufacturer
·
US , Mchenry , IL
Euro-Diagnostics BV - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1984
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Euro-Diagnostics BV
Chemistry
✕
4
devices
1-4 of 4
Filters
Cleared
Jul 09, 1985
BLHI LUTEINIZING HORMONE
K851332
·
CEP
Chemistry
·
96d
Cleared
Apr 29, 1985
TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE
K851148
·
JLW
Chemistry
·
39d
Cleared
Apr 08, 1985
BACI 6 -ADRENOCORTICOTROOP HORMONE
K850053
·
CKG
Chemistry
·
90d
Cleared
Sep 14, 1984
PROLACTIN IRMA
K842478
·
CFT
Chemistry
·
81d
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5
Chemistry
4
Immunology
1