The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for I.v. Start Kit, Sterile, Disposable.
| Device ID | K923361 |
| 510k Number | K923361 |
| Device Name: | I.V. START KIT, STERILE, DISPOSABLE |
| Classification | I.v. Start Kit |
| 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 | LRS |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-08 |
| Decision Date | 1993-06-28 |