HTF WITH ALBUMIN (CATALOG NO. 9994)— 510(k) K894405
Substantially EquivalentIrvine Scientific
FDA 510(k) clearance K894405 for HTF WITH ALBUMIN (CATALOG NO. 9994), Substantially Equivalent on 1989-09-22. Applicant: Irvine Scientific. Device class: 2.
Clearance details
- Applicant
- Irvine Scientific
- Product code
- Code HDR
- Device class
- Class 2
- Regulation
- 21 CFR 884.5250
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.