The following data is part of a premarket notification filed by Stellar Bio Systems, Inc. with the FDA for Ifa For Chlamydia Trachomatis Igg Antibody.
| Device ID | K914953 |
| 510k Number | K914953 |
| Device Name: | IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY |
| Classification | Antisera, Fluorescent, Chlamydia Spp. |
| 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 | LKI |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-05 |
| Decision Date | 1992-02-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813545025533 | K914953 | 000 |
| 00813545025519 | K914953 | 000 |