The following data is part of a premarket notification filed by Hazleton Research Products, Inc. with the FDA for Earle's Mem W/non-essential Amino Acids Powder Med.
| Device ID | K850223 |
| 510k Number | K850223 |
| Device Name: | EARLE'S MEM W/NON-ESSENTIAL AMINO ACIDS POWDER MED |
| Classification | Media And Components, Synthetic Cell And Tissue Culture |
| 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 | KIT |
| CFR Regulation Number | 864.2220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-22 |
| Decision Date | 1985-03-07 |