510(k) K843434

ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC. by Iso-Data, Inc. — Product Code JQC

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