The following data is part of a premarket notification filed by Pro-lab, Inc. with the FDA for Hippurate Hydrolysis Test.
| Device ID | K861888 |
| 510k Number | K861888 |
| Device Name: | HIPPURATE HYDROLYSIS TEST |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | PRO-LAB, INC. 76 GLENGARRY AVENUE TORONTO Ontario Canada M5m 1c9, CA |
| Contact | Lynn Rae |
| Correspondent | Lynn Rae PRO-LAB, INC. 76 GLENGARRY AVENUE TORONTO Ontario Canada M5m 1c9, CA |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-16 |
| Decision Date | 1986-06-03 |