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510(k) K941326

ULTRAFREE-CL by Millipore Corp. — Product Code JJH

K941326 is an FDA 510(k) premarket notification submitted by Millipore Corp. for the device "ULTRAFREE-CL". The FDA issued a decision of Substantially Equivalent on May 27, 1994. The device falls under product code JJH (Clinical Sample Concentrator), a Class I device regulated under 21 CFR 862.2310. Millipore Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1994
Date Received
March 18, 1994
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 Millipore Corp.

  • K023892 — MILLEX VV, GV, AND HV SYRINGE FILTER UNITS (January 17, 2003)
  • K013988 — MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R (April 4, 2002)
  • K963717 — MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) (June 10, 1997)
  • K934069 — MILLEX, DUALEX (PLUS, ULTRA) (April 21, 1994)
  • K924347 — WATERS(TM) 996 PDA (December 11, 1992)
  • K922388 — WATERS(TM) LC MODULE I FOR CLINICAL USE (September 11, 1992)
  • K920136 — WATERS 717 AUTOSAMPLER (February 19, 1992)
  • K914841 — CHROMATOGRAPHY CLINICAL USE 75JQR (December 10, 1991)
  • K903647 — MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE (September 11, 1990)
  • K872792 — WATERS M600E MULTI-SOLVENT DELIVERY SYSTEM (July 31, 1987)

Other clearances for product code JJH

  • K113731 — ESENSOR RESPIRATORY VIRAL PANEL (September 10, 2012)
  • K960298 — VIVASPIN 4 10,000 MW (March 19, 1996)
  • K943966 — VIVAPORE 2 (April 11, 1995)
  • K943965 — VIVAPORE 10 (April 11, 1995)
  • 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