510(k) K865062
K865062 is an FDA 510(k) premarket notification submitted by Analytical Products, Inc. for the device "ALADIN (TM)". The FDA issued a decision of Substantially Equivalent on Mar 25, 1987. The device falls under product code LRG (Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems), a Class II device regulated under 21 CFR 866.1640. Analytical Products, Inc. has 56 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 25, 1987
- Date Received
- Dec 24, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type
- 510(k)