The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Mid-stream Collection Set-sterile.
| Device ID | K953929 |
| 510k Number | K953929 |
| Device Name: | MID-STREAM COLLECTION SET-STERILE |
| Classification | Device, Specimen Collection |
| Applicant | TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 |
| Contact | Partha Basumallik |
| Correspondent | Partha Basumallik TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 |
| Product Code | LIO |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-21 |
| Decision Date | 1995-11-16 |