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510(k) K761013

SPINETTE CENTRIFUGE by Damon Corp. — Product Code JQC

K761013 is an FDA 510(k) premarket notification submitted by Damon Corp. for the device "SPINETTE CENTRIFUGE". The FDA issued a decision of Substantially Equivalent on November 16, 1976. The device falls under product code JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use), a Class I device regulated under 21 CFR 862.2050. Damon Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1976
Date Received
November 9, 1976
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 Damon Corp.

  • K874865 — DAMON D.E.T.E.C.T IMAGE ENHANCER (December 23, 1987)
  • K831826 — ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY (July 18, 1983)
  • K820686 — LIQUISOL PROGESTERONE RADIOIMMUNO (April 1, 1982)
  • K802661 — LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT (December 10, 1980)
  • K790250 — LIQUISOL CORTISOL RIA TEST KIT (April 4, 1979)
  • K782124 — IEC CENTRA-7 CENTRIFUGE MODEL 2362 (February 26, 1979)
  • K781012 — RIA TEST KIT SYS. DAMON KIQUISOL FREE (July 27, 1978)
  • K780207 — LIQUISOL DIGOXIN RIA TEST KIT (February 23, 1978)
  • K770918 — LIQUI SOL T4 RIA TEST KIT (June 17, 1977)
  • K770606 — ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH (May 6, 1977)

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