510(k) K821443
K821443 is an FDA 510(k) premarket notification submitted by Lerner Laboratories, Inc. for the device "FORMICAL". The FDA issued a decision of Substantially Equivalent on June 2, 1982. The device falls under product code KDX (Solution, Decalcifier, Acid Containing), a Class I device regulated under 21 CFR 864.4010. Lerner Laboratories, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 1982
- Date Received
- May 14, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Solution, Decalcifier, Acid Containing
- Device Class
- Class I
- Regulation Number
- 864.4010
- Review Panel
- PA
- Submission Type