The following data is part of a premarket notification filed by Tissue Culture Innovations with the FDA for Dulbecco's Phosphate Buffered Saline W/calcl2.
| Device ID | K860784 |
| 510k Number | K860784 |
| Device Name: | DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2 |
| Classification | Formulations, Balanced Salt Solutions |
| 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 | KIP |
| CFR Regulation Number | 864.2875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-03 |
| Decision Date | 1986-03-12 |