INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M— 510(k) K990847
Substantially EquivalentHumagen Fertility Diagnostics, Inc.
FDA 510(k) clearance K990847 for INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M, Substantially Equivalent on 1999-07-14. Applicant: Humagen Fertility Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Humagen Fertility Diagnostics, Inc.
- Product code
- Code MQH
- Device class
- Class 2
- Regulation
- 21 CFR 884.6130
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Charlottesville, VA, US
Recent devices under product code MQH
view allMore 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
- K000915 — PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75
- K990941 — NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L
- K915229 — SEMEN ANALYSIS KIT
Recalls naming K990847
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 K990847.
Data sourced from openFDA. This site is unofficial and independent of the FDA.