PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75— 510(k) K000915
Substantially EquivalentHumagen Fertility Diagnostics, Inc.
FDA 510(k) clearance K000915 for PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75, Substantially Equivalent on 2000-05-12. Applicant: Humagen Fertility Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Humagen Fertility Diagnostics, Inc.
- Product code
- Code MQK
- Device class
- Class 2
- Regulation
- 21 CFR 884.6160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Charlottesville, VA, US
Recent devices under product code MQK
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- K241341 — cryo-GO Vitrification Device
- K240002 — G-Vitri Vitrification Straw
More clearances from Humagen Fertility Diagnostics, Inc.
view all- K012811 — BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B
- K990847 — INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M
- K990941 — NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L
- K915229 — SEMEN ANALYSIS KIT
Recalls naming K000915
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K000915.
Data sourced from openFDA. This site is unofficial and independent of the FDA.