The following data is part of a premarket notification filed by Hazleton Research Products, Inc. with the FDA for Trypsin 10x - 1:250 In Hbss W/o Ca & Mg.
Device ID | K844878 |
510k Number | K844878 |
Device Name: | TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG |
Classification | Formulations, Balanced Salt Solutions |
Applicant | HAZLETON RESEARCH PRODUCTS, INC. BOX 7200 Denver, PA 17517 |
Contact | James K Noel |
Correspondent | James K Noel HAZLETON RESEARCH PRODUCTS, INC. BOX 7200 Denver, PA 17517 |
Product Code | KIP |
CFR Regulation Number | 864.2875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-17 |
Decision Date | 1985-02-25 |