The following data is part of a premarket notification filed by Tissue Culture Innovations with the FDA for Micro Carrier.
Device ID | K860783 |
510k Number | K860783 |
Device Name: | MICRO CARRIER |
Classification | Media And Components, Synthetic Cell And Tissue Culture |
Applicant | TISSUE CULTURE INNOVATIONS 1580 E. EDINGER, SUITE C SANTA ANA, CA 92705 |
Contact | ROD ROBERTS |
Correspondent | ROD ROBERTS TISSUE CULTURE INNOVATIONS 1580 E. EDINGER, SUITE C SANTA ANA, CA 92705 |
Product Code | KIT |
CFR Regulation Number | 864.2220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-03 |
Decision Date | 1986-03-12 |