The following data is part of a premarket notification filed by Hazleton Research Products, Inc. with the FDA for Dulbecco's Mem With 4.5 G/l Glucose Medium.
| Device ID | K861996 |
| 510k Number | K861996 |
| Device Name: | DULBECCO'S MEM WITH 4.5 G/L GLUCOSE MEDIUM |
| 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 | 1986-05-23 |
| Decision Date | 1986-06-09 |