The following data is part of a premarket notification filed by Pro-lab, Inc. with the FDA for Master Kit B.
| Device ID | K861142 |
| 510k Number | K861142 |
| Device Name: | MASTER KIT B |
| Classification | Tray, Surgical |
| Applicant | PRO-LAB, INC. POST OFFICE BOX 11276 Birmingham, AL 35201 |
| Contact | Dan Mcdonald |
| Correspondent | Dan Mcdonald PRO-LAB, INC. POST OFFICE BOX 11276 Birmingham, AL 35201 |
| Product Code | LRP |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-26 |
| Decision Date | 1986-07-10 |