510(k) K061549
K061549 is an FDA 510(k) premarket notification submitted by Irvine Scientific Sales Co., Inc. for the device "AMNIOSTAT-FLM-PG". The FDA issued a decision of Substantially Equivalent on October 18, 2006. The device falls under product code JHG (Chromatographic Separation, Lecithin/Sphingomyelin Ratio), a Class II device regulated under 21 CFR 862.1455. Irvine Scientific Sales Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2006
- Date Received
- June 5, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chromatographic Separation, Lecithin/Sphingomyelin Ratio
- Device Class
- Class II
- Regulation Number
- 862.1455
- Review Panel
- CH
- Submission Type