510(k) K932122
K932122 is an FDA 510(k) premarket notification submitted by Giles Scientific, Inc. for the device "BIOMIC VIDEO PLATE READER". The FDA issued a decision of Substantially Equivalent on March 1, 1994. The device falls under product code KZK (Reader, Zone, Automated), a Class I device regulated under 21 CFR 866.2850. Giles Scientific, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 1, 1994
- Date Received
- May 3, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reader, Zone, Automated
- Device Class
- Class I
- Regulation Number
- 866.2850
- Review Panel
- MI
- Submission Type