510(k) K790798
K790798 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "FETAL MATURITY TEST PROCEDURE". The FDA issued a decision of Substantially Equivalent on June 5, 1979. The device falls under product code JHG (Chromatographic Separation, Lecithin/Sphingomyelin Ratio), a Class II device regulated under 21 CFR 862.1455. Helena Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 5, 1979
- Date Received
- April 17, 1979
- 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