The following data is part of a premarket notification filed by Hazleton Research Products, Inc. with the FDA for Dmem & Ham's F-12 (1:1) Powdered Medium.
Device ID | K861886 |
510k Number | K861886 |
Device Name: | DMEM & HAM'S F-12 (1:1) POWDERED MEDIUM |
Classification | Media And Components, Synthetic Cell And Tissue Culture |
Applicant | HAZLETON RESEARCH PRODUCTS, INC. BOX 7200 Denver, PA 17517 |
Contact | Noel |
Correspondent | Noel 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 | 1986-05-16 |
Decision Date | 1986-05-29 |