510(k) K860747
K860747 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DU PONT SORVALL CENTRIFUGES (RAPIDSPIN R)". The FDA issued a decision of Substantially Equivalent on April 14, 1986. The device falls under product code JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use), a Class I device regulated under 21 CFR 862.2050. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 1986
- Date Received
- February 27, 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