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510(k) K011598

WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE by Irvine Scientific Sales Co., Inc. — Product Code MTW

K011598 is an FDA 510(k) premarket notification submitted by Irvine Scientific Sales Co., Inc. for the device "WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE". The FDA issued a decision of Substantially Equivalent on June 13, 2001. The device falls under product code MTW (System, Water, Reproduction, Assisted, And Purification), a Class II device regulated under 21 CFR 884.6170. Irvine Scientific Sales Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2001
Date Received
May 24, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Water, Reproduction, Assisted, And Purification
Device Class
Class II
Regulation Number
884.6170
Review Panel
OB
Submission Type

Other clearances by Irvine Scientific Sales Co., Inc.

  • K171224 — Arctic Sperm Cryopreservation Medium (August 31, 2017)
  • K170681 — Continuous Single Culture -NX (CSCM-NX) (June 8, 2017)
  • K170602 — Continuous Single Culture-NX Complete (CSCM-NXC) (June 7, 2017)
  • K121572 — CONTINUOUS SINGLE CULTURE COMPLETE (July 19, 2012)
  • K121128 — MULTIPURPOSE HANDLING MEDIUM (June 6, 2012)
  • K093273 — VIT KIT - FREEZE AND THAW (March 3, 2010)
  • K072609 — SINGLE STEP MEDIUM (February 12, 2008)
  • K072608 — LYOPHILIZED MULTIBLAST MEDIUM KIT (January 30, 2008)
  • K072607 — LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT (January 25, 2008)
  • K061549 — AMNIOSTAT-FLM-PG (October 18, 2006)

Other clearances for product code MTW

  • K993140 — WATER FOR TISSUE CULTURE, MODELS 1500 (August 2, 2000)

FDA data resources