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 |