ClearanceBrief
Company ยท US

Alexon Biomedical, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 1997. Name variants (Inc, Corp, punctuation) are merged.

5510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
GMDAntisera, Latex Agglutination, Cryptococcus Neoformans1
KHWAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.1
LLHReagents, Clostridium Difficile Toxin1
MHIGiardia Spp.1
MHJCryptosporidium Spp.1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Feb 4, 1997K964864PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY
Alexon Biomedical, Inc.
LLH
Feb 9, 1996K955157PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY
Alexon Biomedical, Inc.
MHI
Nov 17, 1994K936191PROSPECT CRYPTOSPORIDIUM RAPID ASSAY
Alexon Biomedical, Inc.
MHJ
Nov 22, 1993K933997PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY
Alexon Biomedical, Inc.
GMD
Jan 5, 1988K874849PROSPECT/GIARDIA
Alexon Biomedical, Inc.
KHW

Latest recalls

DateFirm and productCodeLinked 510(k)
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