Newlife Dish (Etched or Non-Etched, with or Without Lid), Models 14-52, 1452E, 1452EL, 1452L
FDA 510(k) K990941 · Humagen Fertility Diagnostics, Inc.
510(k) numberK990941
Submission
- Device name
- Newlife Dish (Etched or Non-Etched, with or Without Lid), Models 14-52, 1452E, 1452EL, 1452L
- Applicant
- Humagen Fertility Diagnostics, Inc.
Charlottesville, VA, US - Received
- March 22, 1999
- Decision date
- July 14, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQK – Labware, Assisted Reproduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6160
- Specialty
- Obstetrics/Gynecology
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|---|---|---|
| K012811 | Blastomere Biopsy Micropipet, Polar Body Micropipet, Models…MQH · Traditional | 02/11/2002SE |
| K000915 | Pasteur Pipet - Sterile 9, Pasteur Pipet - Sterile 5 3/4, Models 16-PP-9, 16-PP-5.75MQK · Traditional | 05/12/2000SE |
| 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 Newlife Dish (Etched or Non-Etched, with or Without Lid), Models 14-52, 1452E, 1452EL, 1452L cleared by the FDA?
Newlife Dish (Etched or Non-Etched, with or Without Lid), Models 14-52, 1452E, 1452EL, 1452L (K990941) received a 510(k) decision of Substantially Equivalent on July 14, 1999, 114 days after the submission was received.
What is the product code of K990941?
The FDA product code is MQK – Labware, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6160.