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510(k) K960298

VIVASPIN 4 10,000 MW by Vivascience, Inc. — Product Code JJH

K960298 is an FDA 510(k) premarket notification submitted by Vivascience, Inc. for the device "VIVASPIN 4 10,000 MW". The FDA issued a decision of Substantially Equivalent on March 19, 1996. The device falls under product code JJH (Clinical Sample Concentrator), a Class I device regulated under 21 CFR 862.2310. Vivascience, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1996
Date Received
January 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clinical Sample Concentrator
Device Class
Class I
Regulation Number
862.2310
Review Panel
CH
Submission Type

Other clearances by Vivascience, Inc.

  • K943965 — VIVAPORE 10 (April 11, 1995)
  • K943966 — VIVAPORE 2 (April 11, 1995)

Other clearances for product code JJH

  • K113731 — ESENSOR RESPIRATORY VIRAL PANEL (September 10, 2012)
  • K943966 — VIVAPORE 2 (April 11, 1995)
  • K943965 — VIVAPORE 10 (April 11, 1995)
  • K941326 — ULTRAFREE-CL (May 27, 1994)
  • K935496 — NANOSEP N10 (April 26, 1994)
  • K930168 — CENTRICON -50 CONCENTRATOR (August 5, 1993)
  • K893733 — CENTRICON CONCENTRATOR (July 20, 1989)
  • K871290 — CENTRICELL(TM) (August 5, 1987)
  • K870690 — CENTRIPREP CONCENTRATOR (March 19, 1987)
  • K851393 — DUPONT PREP FOUR-SOLVENT RETROFIT KIT (July 12, 1985)

FDA data resources