510(k) K843434
K843434 is an FDA 510(k) premarket notification submitted by Iso-Data, Inc. for the device "ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC.". The FDA issued a decision of Substantially Equivalent on October 5, 1984. The device falls under product code JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use), a Class I device regulated under 21 CFR 862.2050. Iso-Data, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 1984
- Date Received
- September 4, 1984
- 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