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510(k) K790445

ULTRA-FREE by Millipore Corp. — Product Code JRL

K790445 is an FDA 510(k) premarket notification submitted by Millipore Corp. for the device "ULTRA-FREE". The FDA issued a decision of Substantially Equivalent on June 28, 1979. The device falls under product code JRL (Unit, Filter, Membrane), a Class I device regulated under 21 CFR 862.2050. Millipore Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1979
Date Received
March 5, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Filter, Membrane
Device Class
Class I
Regulation Number
862.2050
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)
  • K941326 — ULTRAFREE-CL (May 27, 1994)
  • 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)

Other clearances for product code JRL

  • K822121 — ACRO PACK (August 5, 1982)
  • K820455 — CENTRIFREE MICROPARTITION SYSTEM (March 15, 1982)
  • K820224 — EMIT FREELEVEL SYSTEM I (February 23, 1982)
  • K812750 — IL 703, STAT SEPARATOR (January 26, 1982)
  • K813159 — VACUSHIELD TM (December 8, 1981)
  • K810829 — ACRODISC (April 8, 1981)
  • K801500 — ULTRAFREE CALCIUM FILTER (August 20, 1980)
  • K781043 — CEA-IMMERSIBLE SEPARATOR (September 15, 1978)

FDA data resources