The following data is part of a premarket notification filed by Pro-lab, Inc. with the FDA for Mucolyse.
| Device ID | K850300 |
| 510k Number | K850300 |
| Device Name: | MUCOLYSE |
| Classification | Supplement, Culture Media |
| 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 | JSK |
| CFR Regulation Number | 866.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-22 |
| Decision Date | 1985-03-20 |