The following data is part of a premarket notification filed by Medical Packaging Corp. with the FDA for Chlamydia Trachomatis Specimen Collection Kit.
| Device ID | K915454 |
| 510k Number | K915454 |
| Device Name: | CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT |
| Classification | Device, Specimen Collection |
| Applicant | MEDICAL PACKAGING CORP. 3 BETHESDA METRO CENTER SUITE 750 Bethesda, MD 20814 |
| Contact | Joyce Davis |
| Correspondent | Joyce Davis MEDICAL PACKAGING CORP. 3 BETHESDA METRO CENTER SUITE 750 Bethesda, MD 20814 |
| Product Code | LIO |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-05 |
| Decision Date | 1992-04-08 |