510(k) K864974
K864974 is an FDA 510(k) premarket notification submitted by Norfolk Scientific, Inc. for the device "GENERAL PURPOSE CENTRIFUGE". The FDA issued a decision of Substantially Equivalent on January 9, 1987. The device falls under product code JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use), a Class I device regulated under 21 CFR 862.2050. Norfolk Scientific, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 1987
- Date Received
- December 19, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type