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510(k) K935496

NANOSEP N10 by Intersep , Ltd. — Product Code JJH

K935496 is an FDA 510(k) premarket notification submitted by Intersep , Ltd. for the device "NANOSEP N10". The FDA issued a decision of Substantially Equivalent on April 26, 1994. The device falls under product code JJH (Clinical Sample Concentrator), a Class I device regulated under 21 CFR 862.2310.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1994
Date Received
November 15, 1993
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 for product code JJH

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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)
  • 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