The following data is part of a premarket notification filed by Stellar Bio Systems, Inc. with the FDA for Indirect Fluorescence Assay For Anti-native Dna Igg Antibody.
| Device ID | K990916 |
| 510k Number | K990916 |
| Device Name: | INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY |
| Classification | Anti-dna Indirect Immunofluorescent Solid Phase |
| Applicant | STELLAR BIO SYSTEMS, INC. 9075 GUILFORD RD. Columbia, MD 21046 |
| Contact | John Brewer |
| Correspondent | John Brewer STELLAR BIO SYSTEMS, INC. 9075 GUILFORD RD. Columbia, MD 21046 |
| Product Code | KTL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-18 |
| Decision Date | 1999-04-21 |
| Summary: | summary |