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510(k) K990847

INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M by Humagen Fertility Diagnostics, Inc. — Product Code MQH

K990847 is an FDA 510(k) premarket notification submitted by Humagen Fertility Diagnostics, Inc. for the device "INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M". The FDA issued a decision of Substantially Equivalent on July 14, 1999. The device falls under product code MQH (Microtools, Assisted Reproduction (Pipettes)), a Class II device regulated under 21 CFR 884.6130. Humagen Fertility Diagnostics, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1999
Date Received
March 15, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microtools, Assisted Reproduction (Pipettes)
Device Class
Class II
Regulation Number
884.6130
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)
  • K000915 — PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP- (May 12, 2000)
  • 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 MQH

  • K250838 — Denudation Pipettes (July 3, 2025)
  • K192146 — V-DENUPET (January 28, 2020)
  • K161275 — EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip (January 23, 2017)
  • K152581 — LifeGlobal Micro Tips (April 11, 2016)
  • K151018 — Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pi (January 8, 2016)
  • K150748 — Flexipet Denuding Pipette, Flexipet Manipulation Pipette (December 18, 2015)
  • K133257 — BIOPSY PIPETTES (May 16, 2014)
  • K102480 — INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZO (April 19, 2011)
  • K092554 — BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES (April 30, 2010)
  • K072600 — INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL (May 19, 2008)

FDA data resources