The following data is part of a premarket notification filed by Stellar Bio Systems, Inc. with the FDA for Indirect Fluorescent Assay For Herpes Simplex 1.
| Device ID | K905608 |
| 510k Number | K905608 |
| Device Name: | INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 |
| Classification | Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Applicant | STELLAR BIO SYSTEMS, INC. 9075 GUILFORD RD. Columbia, MD 21046 |
| Contact | John M Brewer |
| Correspondent | John M Brewer STELLAR BIO SYSTEMS, INC. 9075 GUILFORD RD. Columbia, MD 21046 |
| Product Code | GQL |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-14 |
| Decision Date | 1991-11-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813545025731 | K905608 | 000 |
| 00813545025717 | K905608 | 000 |
| 00813545025700 | K905608 | 000 |
| 00813545025687 | K905608 | 000 |