The following data is part of a premarket notification filed by Pro-lab, Inc. with the FDA for Rosco Pyrr.
| Device ID | K894221 |
| 510k Number | K894221 |
| Device Name: | ROSCO PYRR |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | PRO-LAB, INC. P.O. BOX 503 Round Rock, TX 78664 |
| Contact | Kay Baitz |
| Correspondent | Kay Baitz PRO-LAB, INC. P.O. BOX 503 Round Rock, TX 78664 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-19 |
| Decision Date | 1989-09-28 |