510(k) K934473
K934473 is an FDA 510(k) premarket notification submitted by Touch Scientific, Inc. for the device "LACTOFERRIN MICROASSAY SYSTEM". The FDA issued a decision of Substantially Equivalent on December 3, 1993. The device falls under product code DEG (Lactoferrin, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5570. Touch Scientific, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 1993
- Date Received
- September 14, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lactoferrin, Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.5570
- Review Panel
- IM
- Submission Type