AMNIOSTAT-FLM-PG— 510(k) K061549
Substantially EquivalentIrvine Scientific Sales Co., Inc.
FDA 510(k) clearance K061549 for AMNIOSTAT-FLM-PG, Substantially Equivalent on 2006-10-18. Applicant: Irvine Scientific Sales Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Irvine Scientific Sales Co., Inc.
- Product code
- Code JHG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1455
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
Recent devices under product code JHG
view allMore clearances from Irvine Scientific Sales Co., Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.