510(k) K834616
K834616 is an FDA 510(k) premarket notification submitted by Hana Biologics, Inc. for the device "AMNIO STAT-FLM AGGLUTINATION TEST". The FDA issued a decision of Substantially Equivalent on May 25, 1984. The device falls under product code JHG (Chromatographic Separation, Lecithin/Sphingomyelin Ratio), a Class II device regulated under 21 CFR 862.1455. Hana Biologics, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 25, 1984
- Date Received
- December 14, 1983
- 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