510(k) K862457
K862457 is an FDA 510(k) premarket notification submitted by Australian Biomedical Corporation , Ltd. for the device "LYNX EL MICROSCOPY TISSUE PROCESSOR". The FDA issued a decision of Substantially Equivalent on July 16, 1986. The device falls under product code IDZ (Cassettes, Tissue), a Class I device regulated under 21 CFR 864.3010. Australian Biomedical Corporation , Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 1986
- Date Received
- June 30, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cassettes, Tissue
- Device Class
- Class I
- Regulation Number
- 864.3010
- Review Panel
- PA
- Submission Type