FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA
K Number: K083509
·
Decision Apr 24, 2009
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
253
Applicant Total
8
Review Days
149
Basic Information
- Device Name
- LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA
- K Number
- K083509
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6180
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- GENX INTL., INC.
- Date Received
- November 26, 2008
- Decision Date
- April 24, 2009
- Product Code
- MQL
- 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 |
|---|---|---|---|
| MQL | Media, Reproductive | 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 |
| K070689 | LG SPERM FREEZING | Jul 3, 2007 | Substantially Equivalent |
| K020560 | WORKBENCH BY <GENX> | Jun 19, 2002 | Substantially Equivalent |
| K962816 | SPERM PREPARATION MEDIA | Nov 26, 1996 | Substantially Equivalent |
| K963031 | GENXCATHETER | Oct 21, 1996 | Substantially Equivalent |