510(k) K813216
K813216 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "SECURE FDI TEST KIT". The FDA issued a decision of Substantially Equivalent on Dec 17, 1981. The device falls under product code JHG (Chromatographic Separation, Lecithin/Sphingomyelin Ratio), a Class II device regulated under 21 CFR 862.1455. Beckman Instruments, Inc. has 280 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 17, 1981
- Date Received
- Nov 9, 1981
- 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
- 510(k)