The following data is part of a premarket notification filed by Touch Scientific, Inc. with the FDA for Lactocard.
Device ID | K931901 |
510k Number | K931901 |
Device Name: | LACTOCARD |
Classification | Lactoferrin, Antigen, Antiserum, Control |
Applicant | TOUCH SCIENTIFIC, INC. 3209 GRESHAM LAKE RD. SUITE 112 Raleigh, NC 27615 |
Contact | Pierce Youngbar |
Correspondent | Pierce 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 | 1993-04-19 |
Decision Date | 1993-07-06 |