PHENOL RED STOCK SOLUTION
FDA 510(k) clearance K032887 · decided 2003-12-19
Clearance details
- K-number
- K032887
- Device name
- PHENOL RED STOCK SOLUTION
- Applicant
- Irvine Scientific Sales Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-16
- Decision date
- 2003-12-19
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- MQL
- Device class
- 2
- Regulation number
- 884.6180
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.