510(k) K893885
K893885 is an FDA 510(k) premarket notification submitted by Catachem, Inc. for the device "BACTON TM, BASIC TM, APO A-I REAGENT". The FDA issued a decision of Substantially Equivalent on June 21, 1989. The device falls under product code DEL (Lipoprotein X, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5590. Catachem, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 1989
- Date Received
- May 30, 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