FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
<GENX> CODA INCUBATOR CELLMATE
K Number: K001600
·
Decision Nov 22, 2000
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
45
Applicant Total
24
Review Days
182
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Basic Information
- Device Name
- <GENX> CODA INCUBATOR CELLMATE
- K Number
- K001600
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6120
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- <Genx> Intl., Inc.
- Date Received
- May 24, 2000
- Decision Date
- November 22, 2000
- Product Code
- MQG
- 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 |
|---|---|---|---|
| MQG | Accessory, Assisted Reproduction | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by <Genx> Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K112083 | LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES | May 3, 2012 | Substantially Equivalent |
| K080395 | SUNIVF DISHES | Aug 13, 2008 | Substantially Equivalent |
| K053552 | GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA | May 19, 2006 | Substantially Equivalent |
| K053551 | MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL | May 9, 2006 | Substantially Equivalent |
| K040530 | MEDIA CULTURE SYSTEM | Jun 25, 2004 | Substantially Equivalent |
| K023033 | ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM) | Nov 26, 2002 | Substantially Equivalent |
| K022590 | PVP (POLYVINYLPYRROLIDONE) | Aug 30, 2002 | Substantially Equivalent |
| K022352 | HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS) | Aug 28, 2002 | Substantially Equivalent |
| K022547 | ACIDIFIED TYRODES SOLUTION | Aug 28, 2002 | Substantially Equivalent |
| K022334 | HTF PLUS - HTF WITH NON-ESSENTIAL AMINO ACIDS | Aug 28, 2002 | Substantially Equivalent |