# Humagen Fertility Diagnostics, Inc.

- Location (FDA's records): Charlottesville, VA
- FDA decisions: 5 (1994–2002): 5 510(k) clearances
- Product codes: MQH (2), MQK (2), POV (1)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 10 (1 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Jieying Laboratory, Inc.: 2 (https://510kreport.com/company/jieying-laboratory)
- Thermo Fisher Scientific (Nalge Nunc Intl): 1 (https://510kreport.com/company/thermo-fisher-scientific-nalge-nunc-intl)
- Genosis, Ltd.: 1 (https://510kreport.com/company/genosis)
- Hertart: 1 (https://510kreport.com/company/hertart)
- Research Instruments, Ltd.: 1 (https://510kreport.com/company/research-instruments)
- Brinkmann Instruments, Inc.: 1 (https://510kreport.com/company/brinkmann-instruments)
- Sunlight Medical, Inc.: 1 (https://510kreport.com/company/sunlight-medical)
- Embryotech Laboratories, Inc.: 1 (https://510kreport.com/company/embryotech-laboratories)

## Its most-cited devices
- K012811: Blastomere Biopsy Micropipet, Polar Body Micropipet, Models 10-MBB,10-MBB-B,10-MPB,10-MPB-B (2002), cited by 3
- K990847: Intracytoplasmic Sperm Injection Micropipets (Icsi) Spermatid Icsi Micropipets, Holding Micropipets, Assisted Hatching M (1999), cited by 3
- K915229: Semen Analysis Kit (1994), cited by 2
- K990941: Newlife Dish (Etched or Non-Etched, with or Without Lid), Models 14-52, 1452E, 1452EL, 1452L (1999), cited by 1
- K000915: Pasteur Pipet - Sterile 9, Pasteur Pipet - Sterile 5 3/4, Models 16-PP-9, 16-PP-5.75 (2000), cited by 1

## Recent decisions
- K012811: Blastomere Biopsy Micropipet, Polar Body Micropipet, Models 10-MBB,10-MBB-B,10-MPB,10-MPB-B (Feb 11, 2002)
- K000915: Pasteur Pipet - Sterile 9, Pasteur Pipet - Sterile 5 3/4, Models 16-PP-9, 16-PP-5.75 (May 12, 2000)
- K990847: Intracytoplasmic Sperm Injection Micropipets (Icsi) Spermatid Icsi Micropipets, Holding Micropipets, Assisted Hatching M (Jul 14, 1999)
- K990941: Newlife Dish (Etched or Non-Etched, with or Without Lid), Models 14-52, 1452E, 1452EL, 1452L (Jul 14, 1999)
- K915229: Semen Analysis Kit (Aug 30, 1994)

Source page: https://510kreport.com/company/humagen-fertility-diagnostics