FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IVC THREE BLASTOCYST MEDIUM, CAT # 2007
K Number: K001113
·
Decision Jun 13, 2000
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
253
Applicant Total
10
Review Days
68
Basic Information
- Device Name
- IVC THREE BLASTOCYST MEDIUM, CAT # 2007
- K Number
- K001113
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6180
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- INVITROCARE, INC.
- Date Received
- April 6, 2000
- Decision Date
- June 13, 2000
- 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 INVITROCARE, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K023222 | ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12 | Dec 26, 2002 | Substantially Equivalent |
| K003751 | HYALURONIDASE REAGENT, MODEL CAT#2212 | Jan 17, 2001 | Substantially Equivalent |
| K001967 | PVP-POLYVINYLPYRROLIDONE REAGENT, MODEL CAT#2210 | Aug 14, 2000 | Substantially Equivalent |
| K000989 | SPERM WASH MEDIUM, CAT# 2003/2005 | Jun 8, 2000 | Substantially Equivalent |
| K000938 | IVC ONE MEDIUM | May 25, 2000 | Substantially Equivalent |
| K000937 | IVC TWO MEDIUM | May 25, 2000 | Substantially Equivalent |
| K993484 | Q-HTF, CAT# 2001 | May 25, 2000 | Substantially Equivalent |
| K000939 | HTF-HEPES | May 4, 2000 | Substantially Equivalent |
| K000940 | HUMAN SERUM ALBUMIN (HSA) | May 4, 2000 | Substantially Equivalent |