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Manufacturers
US
Repromedix Corp.
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Medical Device Manufacturer
·
US , Woburn , MA
Repromedix Corp. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2000
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Repromedix Corp.
Chemistry
✕
3
devices
1-3 of 3
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Cleared
Oct 05, 2000
REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)
K001603
·
KLI
Chemistry
·
134d
Cleared
Oct 05, 2000
REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)
K001606
·
JLW
Chemistry
·
134d
Cleared
Oct 05, 2000
REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)
K001607
·
CDP
Chemistry
·
134d
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3
Chemistry
3