The following data is part of a premarket notification filed by Clonetics Corp. with the FDA for Keratinocyte Growth Medium (kgm).
| Device ID | K881000 |
| 510k Number | K881000 |
| Device Name: | KERATINOCYTE GROWTH MEDIUM (KGM) |
| Classification | Media And Components, Synthetic Cell And Tissue Culture |
| Applicant | CLONETICS CORP. 9620 CHESAPEAKE DR. SUITE 206 San Diego, CA 92123 -1324 |
| Contact | Michael C Luecke |
| Correspondent | Michael C Luecke CLONETICS CORP. 9620 CHESAPEAKE DR. SUITE 206 San Diego, CA 92123 -1324 |
| Product Code | KIT |
| CFR Regulation Number | 864.2220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-08 |
| Decision Date | 1988-03-21 |