510(k) K881465
K881465 is an FDA 510(k) premarket notification submitted by Cryodyne Technologies, Inc. for the device "CRYOBIOLOGICAL FREEZER". The FDA issued a decision of Substantially Equivalent on April 21, 1988. The device falls under product code KSP (Apparatus, Cell-Freezing And Reagents), a Class I device regulated under 21 CFR 864.9225. Cryodyne Technologies, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1988
- Date Received
- April 6, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Cell-Freezing And Reagents
- Device Class
- Class I
- Regulation Number
- 864.9225
- Review Panel
- HE
- Submission Type