510(k) K861336
K861336 is an FDA 510(k) premarket notification submitted by Scientific Sales Intl., Inc. for the device "IAP PLATE TEST". The FDA issued a decision of Substantially Equivalent on April 25, 1986. The device falls under product code LKL (Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5420. Scientific Sales Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 1986
- Date Received
- April 9, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.5420
- Review Panel
- IM
- Submission Type