510(k) K761001
K761001 is an FDA 510(k) premarket notification submitted by Lerner Laboratories, Inc. for the device "PAP-TRAY II (CATALOG #C600-2)". The FDA issued a decision of Substantially Equivalent on December 6, 1976. The device falls under product code LEA (Preservative, Cytological), 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
- December 6, 1976
- Date Received
- November 8, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Preservative, Cytological
- Device Class
- Class I
- Regulation Number
- 864.4010
- Review Panel
- PA
- Submission Type