510(k) K821831
K821831 is an FDA 510(k) premarket notification submitted by Warner-Lambert Co. for the device "A O HISTOSTAT EMBEDDING CTR #8030,32,34". The FDA issued a decision of Substantially Equivalent on July 13, 1982. The device falls under product code IDS (Melting Pot, Paraffin), a Class I device regulated under 21 CFR 864.3010. Warner-Lambert Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 1982
- Date Received
- June 22, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Melting Pot, Paraffin
- Device Class
- Class I
- Regulation Number
- 864.3010
- Review Panel
- PA
- Submission Type