FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216
K Number: K080172
·
Decision Dec 18, 2008
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
253
Applicant Total
26
Review Days
329
Basic Information
- Device Name
- BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216
- K Number
- K080172
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6180
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDICULT A/S
- Date Received
- January 24, 2008
- Decision Date
- December 18, 2008
- 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 MEDICULT A/S
| K Number | Device Name | ||
|---|---|---|---|
| K081639 | ICSI CUMULASE | Sep 19, 2008 | Substantially Equivalent |
| K080473 | EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED | Sep 3, 2008 | Substantially Equivalent |
| K061309 | EMBRYOASSIST | Feb 8, 2007 | Substantially Equivalent |
| K061145 | SPERMSLOW | Oct 2, 2006 | Substantially Equivalent |
| K060983 | BIOPSY MEDIUM, MODEL REF 1062 | Jul 28, 2006 | Substantially Equivalent |
| K060699 | SYNVITRO CUMULASE (HYALURONIDASE MEDIUM) | May 10, 2006 | Substantially Equivalent |
| K041284 | MEDICULT IVM SYSTEM | Nov 22, 2004 | Substantially Equivalent |
| K030490 | ISM1+, IMS2+, AND UTM+ | Aug 20, 2003 | Substantially Equivalent |
| K031486 | BLASTFREEZE AND BLASTTHAW | Jun 27, 2003 | Substantially Equivalent |
| K031228 | SYNVITRO HYADASE | Jun 24, 2003 | Substantially Equivalent |