The following data is part of a premarket notification filed by Stellar Bio Systems, Inc. with the FDA for Indirect Fluorescent Assay For (hcmv).
| Device ID | K882835 |
| 510k Number | K882835 |
| Device Name: | INDIRECT FLUORESCENT ASSAY FOR (HCMV) |
| Classification | Antigen, Cf (including Cf Control), Cytomegalovirus |
| 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 | GQH |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-08 |
| Decision Date | 1988-12-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813545025502 | K882835 | 000 |
| 00813545025489 | K882835 | 000 |