510(k) K800524
K800524 is an FDA 510(k) premarket notification submitted by Miles Laboratories, Inc. for the device "SERALYZER REFLECTANCE PHOTOMETER/CALIB.". The FDA issued a decision of Substantially Equivalent on April 2, 1980. The device falls under product code CIE (Volumetric/Manometric, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Miles Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 2, 1980
- Date Received
- March 6, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Volumetric/Manometric, Carbon-Dioxide
- Device Class
- Class II
- Regulation Number
- 862.1160
- Review Panel
- CH
- Submission Type