Home / 510(k) Clearances / K100596

510(k) K100596

CRYOPETTE by Mid-Atlantic Diagnostics, Inc. — Product Code MQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2010
Date Received
March 2, 2010
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 Mid-Atlantic Diagnostics, Inc.

  • K041435 — THE STRIPPER PGD (September 29, 2004)
  • K030525 — CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24 (August 27, 2003)
  • K993699 — THE STRIPPER (May 16, 2000)

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)