The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Bartels Herpes Simplex Vir Flu Mono Antibody Test.
| Device ID | K902662 |
| 510k Number | K902662 |
| Device Name: | BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST |
| Classification | Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 3093 Bellevue, WA 98009 |
| Contact | Lorraine W Huffman |
| Correspondent | Lorraine W Huffman BAXTER HEALTHCARE CORP. P.O. BOX 3093 Bellevue, WA 98009 |
| Product Code | GQL |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-18 |
| Decision Date | 1990-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516745949 | K902662 | 000 |
| 05391516745932 | K902662 | 000 |
| 05391516745925 | K902662 | 000 |
| 05391516745918 | K902662 | 000 |