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510(k) K000915

PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 by Humagen Fertility Diagnostics, Inc. — Product Code MQK

K000915 is an FDA 510(k) premarket notification submitted by Humagen Fertility Diagnostics, Inc. for the device "PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75". The FDA issued a decision of Substantially Equivalent on May 12, 2000. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160. Humagen Fertility Diagnostics, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2000
Date Received
March 22, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Labware, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6160
Review Panel
OB
Submission Type

Other clearances by Humagen Fertility Diagnostics, Inc.

  • K012811 — BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-M (February 11, 2002)
  • K990847 — INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, (July 14, 1999)
  • K990941 — NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1 (July 14, 1999)
  • K915229 — SEMEN ANALYSIS KIT (August 30, 1994)

Other clearances for product code MQK

  • K241626 — SperSort™ Sperm Sorting Chip (IPG02) (February 20, 2025)
  • K241454 — Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT (February 3, 2025)
  • K241348 — SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) (January 31, 2025)
  • K241341 — cryo-GO Vitrification Device (September 26, 2024)
  • K240002 — G-Vitri™ Vitrification Straw (June 14, 2024)
  • K232980 — SpermAlign Sperm Separation Device (March 14, 2024)
  • K233177 — Nest VT Vitrification Device (March 8, 2024)
  • K221810 — LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device (October 31, 2022)
  • K213869 — EmbryoSlide+ ic8 dish (March 11, 2022)
  • K203626 — SureStrip Vitrification Straw, SureLock Vitrification Straw (June 4, 2021)

FDA data resources