510(k) K813430
K813430 is an FDA 510(k) premarket notification submitted by American Optical Corp. for the device "TISSUE PROCESSING CASSETTES & ACCESS". The FDA issued a decision of Substantially Equivalent on December 29, 1981. The device falls under product code IDL (Microtome, Accessories), a Class I device regulated under 21 CFR 864.3010. American Optical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 1981
- Date Received
- December 8, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Microtome, Accessories
- Device Class
- Class I
- Regulation Number
- 864.3010
- Review Panel
- PA
- Submission Type