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 |