FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPERM PREPARATION MEDIA
K Number: K962816
·
Decision Nov 26, 1996
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
22
Applicant Total
8
Review Days
130
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Basic Information
- Device Name
- SPERM PREPARATION MEDIA
- K Number
- K962816
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genx Intl., Inc.
- Date Received
- July 19, 1996
- Decision Date
- November 26, 1996
- Product Code
- MOL
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MOL | Condom, Synthetic | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Genx Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K092963 | GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 | Jan 14, 2011 | Substantially Equivalent |
| K092667 | GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT | Jun 3, 2010 | Substantially Equivalent |
| K092578 | LIFEGLOBAL PROTEIN SUPPLEMENT | Apr 5, 2010 | Substantially Equivalent |
| K083509 | LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA | Apr 24, 2009 | Substantially Equivalent |
| K070689 | LG SPERM FREEZING | Jul 3, 2007 | Substantially Equivalent |
| K020560 | WORKBENCH BY <GENX> | Jun 19, 2002 | Substantially Equivalent |
| K963031 | GENXCATHETER | Oct 21, 1996 | Substantially Equivalent |