The following data is part of a premarket notification filed by Stellar Bio Systems, Inc. with the FDA for Indirect Fluorescent Assay For (ebv-vca) Igg Anti..
| Device ID | K900974 |
| 510k Number | K900974 |
| Device Name: | INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. |
| Classification | Antiserum, Fluorescent, Epstein-barr Virus |
| 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 | JRY |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-02 |
| Decision Date | 1990-04-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813545025564 | K900974 | 000 |
| 00813545025540 | K900974 | 000 |