The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Antibody To Chlamydia Trachomatis.
| Device ID | K811570 |
| 510k Number | K811570 |
| Device Name: | ANTIBODY TO CHLAMYDIA TRACHOMATIS |
| Classification | Antigen, Cf, Psittacosis (chlamydia Group) |
| Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GPW |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-04 |
| Decision Date | 1981-07-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G5229030011 | K811570 | 000 |
| G5229030001 | K811570 | 000 |