510(k) K852737
K852737 is an FDA 510(k) premarket notification submitted by Mackeen Consultants, Ltd. for the device "LACTOPLATE". The FDA issued a decision of Substantially Equivalent on October 25, 1985. The device falls under product code DEG (Lactoferrin, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5570. Mackeen Consultants, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 1985
- Date Received
- June 27, 1985
- 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