510(k) K951101
K951101 is an FDA 510(k) premarket notification submitted by Techlab, Inc. for the device "LEUKO-TEST". The FDA issued a decision of Substantially Equivalent on April 24, 1995. The device falls under product code DEG (Lactoferrin, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5570. Techlab, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 24, 1995
- Date Received
- March 10, 1995
- 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