The following data is part of a premarket notification filed by Touch Scientific, Inc. with the FDA for Touch Tear Ige Microassay Kit.
| Device ID | K991316 |
| 510k Number | K991316 |
| Device Name: | TOUCH TEAR IGE MICROASSAY KIT |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | TOUCH SCIENTIFIC, INC. 3209 GRESHAM LAKE RD. SUITE 112 Raleigh, NC 27615 |
| Contact | Alan J Touch |
| Correspondent | Alan J Touch TOUCH SCIENTIFIC, INC. 3209 GRESHAM LAKE RD. SUITE 112 Raleigh, NC 27615 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-19 |
| Decision Date | 1999-08-09 |