Blastomere Biopsy Micropipet, Polar Body Micropipet, Models 10-MBB,10-MBB-B,10-MPB,10-MPB-B
FDA 510(k) K012811 · Humagen Fertility Diagnostics, Inc.
510(k) numberK012811
Submission
- Device name
- Blastomere Biopsy Micropipet, Polar Body Micropipet, Models 10-MBB,10-MBB-B,10-MPB,10-MPB-B
- Applicant
- Humagen Fertility Diagnostics, Inc.
Charlottesville, VA, US - Received
- August 22, 2001
- Decision date
- February 11, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQH – Microtools, Assisted Reproduction (Pipettes)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6130
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MQH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250838 | Denudation PipettesMQH · Traditional | Guangzhou Pinzhi Medical Device Co., Ltd. | 07/03/2025SE |
| K192146 | V-DenupetMQH · Traditional | Vitromed GmbH | 01/28/2020SE |
| K161275 | EZ-Tip Singles, EZ-Tip Vial of 20, EZ-GripMQH · Traditional | Research Instruments Limited | 01/23/2017SE |
| K152581 | LifeGlobal Micro TipsMQH · Traditional | Life Global Group, LLC | 04/11/2016SE |
| K151018 | Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction PipetteMQH · Traditional | Cook Incorporated | 01/08/2016SE |
| K150748 | Flexipet Denuding Pipette, Flexipet Manipulation PipetteMQH · Traditional | Cook Incorporated | 12/18/2015SE |
| K133257 | Biopsy PipettesMQH · Traditional | Research Instruments , Ltd. | 05/16/2014SE |
| K102480 | Injection Pipette; Holding Pipette; Biopsy Pipette; Denuding Pipette; Partial Zona…MQH · Traditional | Jieying Laboratory, Inc. | 04/19/2011SE |
| K092554 | Blastomere Biopsy Pipettes, Polar Body Biopsy PipettesMQH · Traditional | Sunlight Medical, Inc. | 04/30/2010SE |
| K072600 | Intracytoplasmic Sperm and Spermatid Injection, Holding, Zone Drilling, Partial Zone…MQH · Traditional | Sunlight Medical, Inc. | 05/19/2008SE |
More from Sunlight Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K000915 | Pasteur Pipet - Sterile 9, Pasteur Pipet - Sterile 5 3/4, Models 16-PP-9, 16-PP-5.75MQK · Traditional | 05/12/2000SE |
| K990941 | Newlife Dish (Etched or Non-Etched, with or Without Lid), Models 14-52, 1452E, 1452EL…MQK · Traditional | 07/14/1999SE |
| K990847 | Intracytoplasmic Sperm Injection Micropipets (Icsi) Spermatid Icsi Micropipets, Holding…MQH · Traditional | 07/14/1999SE |
| K915229 | Semen Analysis KitPOV · Traditional | 08/30/1994SE |
Questions and answers
When was Blastomere Biopsy Micropipet, Polar Body Micropipet, Models 10-MBB,10-MBB-B,10-MPB,10-MPB-B cleared by the FDA?
Blastomere Biopsy Micropipet, Polar Body Micropipet, Models 10-MBB,10-MBB-B,10-MPB,10-MPB-B (K012811) received a 510(k) decision of Substantially Equivalent on February 11, 2002, 173 days after the submission was received.
What is the product code of K012811?
The FDA product code is MQH – Microtools, Assisted Reproduction (Pipettes), a Class II (moderate risk) device regulated under 21 CFR 884.6130.