BOVINE SERUM ALBUMIN (BSA)
FDA 510(k) clearance K991338 · decided 1999-07-14
Clearance details
- K-number
- K991338
- Device name
- BOVINE SERUM ALBUMIN (BSA)
- Applicant
- Irvine Scientific Sales Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-04-19
- Decision date
- 1999-07-14
- Days to decision
- 86 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.