FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WATER FOR TISSUE CULTURE, MODELS 1500
K Number: K993140
·
Decision Aug 2, 2000
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
8
Review Days
317
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- WATER FOR TISSUE CULTURE, MODELS 1500
- K Number
- K993140
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6170
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Conception Technologies
- Date Received
- September 20, 1999
- Decision Date
- August 2, 2000
- Product Code
- MTW
- 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 |
|---|---|---|---|
| MTW | System, Water, Reproduction, Assisted, And Purification | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MTW), ordered by most recent decision date.
View allOther Clearances by Conception Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K030850 | ENHANCE HUMAN SERUM ALBUMIN | Apr 8, 2003 | Substantially Equivalent |
| K023655 | ENHANCE HTF MEDIUM WITH HEPES | Dec 13, 2002 | Substantially Equivalent |
| K023717 | SPERM WASH MEDIUM WITH GENTAMICIN | Dec 13, 2002 | Substantially Equivalent |
| K020490 | PBS, PBSW WITH CATIONS AND PHENOL RED | Mar 28, 2002 | Substantially Equivalent |
| K011481 | 10% PVP; 10% PVP IN EBSS SOLUTION | Jul 2, 2001 | Substantially Equivalent |
| K011573 | HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM | Jul 2, 2001 | Substantially Equivalent |
| K011462 | OIL FOR TISSUE CULTURE | Jun 13, 2001 | Substantially Equivalent |