510(k) K884297
K884297 is an FDA 510(k) premarket notification submitted by Atlantic Antibodies for the device "SPQ(TM) TEST SYSTEM FOR PREALBUMIN". The FDA issued a decision of Substantially Equivalent on November 2, 1988. The device falls under product code JZJ (Prealbumin, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5060. Atlantic Antibodies has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 1988
- Date Received
- October 12, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prealbumin, Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.5060
- Review Panel
- IM
- Submission Type