The following data is part of a premarket notification filed by Hazleton Research Products, Inc. with the FDA for Minimum Essential Med. (eagle) W/25mm Hepes Buffer.
Device ID | K861874 |
510k Number | K861874 |
Device Name: | MINIMUM ESSENTIAL MED. (EAGLE) W/25MM HEPES BUFFER |
Classification | Media And Components, Synthetic Cell And Tissue Culture |
Applicant | HAZLETON RESEARCH PRODUCTS, INC. BOX 7200 Denver, PA 17517 |
Contact | Noel, Ph.d. |
Correspondent | Noel, Ph.d. HAZLETON RESEARCH PRODUCTS, INC. BOX 7200 Denver, PA 17517 |
Product Code | KIT |
CFR Regulation Number | 864.2220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-05-15 |
Decision Date | 1986-05-29 |