ClearanceBrief
Company

Binax, Inc. dba IMPD

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

0510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
4recalls that name a 510(k)

Product codes

CodeDeviceRecords
GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, C4
GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus1
GTZAntisera, All Groups, Streptococcus Spp.1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
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Latest recalls

DateFirm and productCodeLinked 510(k)
Jun 24, 2009Binax, Inc. dba IMPD
Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnostic.
Terminated		 GTZK962060
May 23, 2007Binax, Inc. dba IMPD
BinaxNOW A&B Kit 10 Test Kit (Japan) Part No. 416-110J contains NP Swabs with '8995' labeled on the swab wrapper
Terminated		 GNXNone listed
May 23, 2007Binax, Inc. dba IMPD
BinaxNOW Nasopharyngeal (NP) Accessory Pak, Part Number 400-065, contain NP Swabs with '8995' labeled on the swab wrapper
Terminated		 GNXNone listed
May 23, 2007Binax, Inc. dba IMPD
BinaxNOW RSV 10 Test Kit Part Number : 430-100, contains NP Swabs with '8995' labeled on the swab wrapper
Terminated		 GQGK032166
May 23, 2007Binax, Inc. dba IMPD
BinaxNOW Influenza A&B 22 Test Kit Part Number: 416-022, contains NP Swabs with '8995' labeled on the swab wrapper
Terminated		 GNXK062109
May 23, 2007Binax, Inc. dba IMPD
BinaxNOW Influenza A&B 10 Test KIT Part Number: 416-110 contains NP Swabs with '8995' labeled on the swab wrapper
Terminated		 GNXK062109
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