The following data is part of a premarket notification filed by Bartels Immunodiagnostic Supplies, Inc. with the FDA for Chlamydiae Immunoperoxidase Test Kit.
| Device ID | K842151 |
| 510k Number | K842151 |
| Device Name: | CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT |
| Classification | Antisera, Immunoperoxidase, Chlamydia Spp. |
| Applicant | BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LKH |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-30 |
| Decision Date | 1984-07-20 |