The following data is part of a premarket notification filed by Touch Scientific, Inc. with the FDA for Lactoferrin Microassay System.
| Device ID | K934473 |
| 510k Number | K934473 |
| Device Name: | LACTOFERRIN MICROASSAY SYSTEM |
| Classification | Lactoferrin, Antigen, Antiserum, Control |
| Applicant | TOUCH SCIENTIFIC, INC. 3209 GRESHAM LAKE RD. SUITE 112 Raleigh, NC 27615 |
| Contact | Pierce R Youngbar |
| Correspondent | Pierce R Youngbar TOUCH SCIENTIFIC, INC. 3209 GRESHAM LAKE RD. SUITE 112 Raleigh, NC 27615 |
| Product Code | DEG |
| CFR Regulation Number | 866.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-14 |
| Decision Date | 1993-12-03 |