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510(k) K881254

STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01 by Norfolk Scientific, Inc. — Product Code JQC

K881254 is an FDA 510(k) premarket notification submitted by Norfolk Scientific, Inc. for the device "STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01". The FDA issued a decision of Substantially Equivalent on April 5, 1988. 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
April 5, 1988
Date Received
March 23, 1988
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

Other clearances by Norfolk Scientific, Inc.

  • K902028 — STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER (June 20, 1990)
  • K890669 — STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE (March 8, 1989)
  • K883185 — SAFECRIT PLASTIC MICROHEMATOCRIT TUBES (August 18, 1988)
  • K870511 — CHART-TYPE MICRO HEMATOCRIT TUBE READER (March 16, 1987)
  • K864974 — GENERAL PURPOSE CENTRIFUGE (January 9, 1987)
  • K860172 — QWIKSPIN (TM) (February 11, 1986)

Other clearances for product code JQC

  • K183205 — PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiol (May 30, 2019)
  • K103340 — SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM (December 6, 2010)
  • K081345 — AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY) (July 10, 2008)
  • K071934 — MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT (October 11, 2007)
  • K070666 — GENESISCS COMPONENT CONCENTRATING SYSTEM (June 20, 2007)
  • K052925 — SMARTPREP2 CENTRIFUGE SYSTEM (January 4, 2006)
  • K042473 — COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM (November 19, 2004)
  • K024080 — SECQUIRE CELL SEPARATOR (July 2, 2003)
  • K030340 — AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) (April 11, 2003)
  • K030555 — GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A (April 11, 2003)

FDA data resources