The following data is part of a premarket notification filed by Integrated Biotechnology Corp. with the FDA for Quicklab Rsv.
Device ID | K021789 |
510k Number | K021789 |
Device Name: | QUICKLAB RSV |
Classification | Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
Applicant | INTEGRATED BIOTECHNOLOGY CORP. 366 RIDGEPOINT DR. Carmel, IN 46032 |
Contact | Sally A Booth |
Correspondent | Sally A Booth INTEGRATED BIOTECHNOLOGY CORP. 366 RIDGEPOINT DR. Carmel, IN 46032 |
Product Code | GQG |
CFR Regulation Number | 866.3480 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-31 |
Decision Date | 2002-11-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00722066008034 | K021789 | 000 |