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 |