510(k) K895160
K895160 is an FDA 510(k) premarket notification submitted by Medical Marketing Consultants, Inc. for the device "ORTHO *APO A-1 ELISA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on October 6, 1989. The device falls under product code DEL (Lipoprotein X, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5590. Medical Marketing Consultants, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 6, 1989
- Date Received
- August 23, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lipoprotein X, Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.5590
- Review Panel
- IM
- Submission Type