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510(k) K871290

CENTRICELL(TM) by Polysciences, Inc. — Product Code JJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1987
Date Received
March 31, 1987
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 Polysciences, Inc.

  • K923349 — FUNGI FLUOR KIT (October 20, 1992)
  • K780146 — T3 STI KIT (February 23, 1978)

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  • K960298 — VIVASPIN 4 10,000 MW (March 19, 1996)
  • K943965 — VIVAPORE 10 (April 11, 1995)
  • K943966 — VIVAPORE 2 (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)
  • K870690 — CENTRIPREP CONCENTRATOR (March 19, 1987)
  • K851393 — DUPONT PREP FOUR-SOLVENT RETROFIT KIT (July 12, 1985)