510(k) K950383
K950383 is an FDA 510(k) premarket notification submitted by Randox Laboratories, Ltd. for the device "APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT". The FDA issued a decision of Substantially Equivalent on Sep 15, 1995. The device falls under product code JHN (Turbidimetric Method, Lipoproteins), a Class I device regulated under 21 CFR 862.1475. Randox Laboratories, Ltd. has 115 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 15, 1995
- Date Received
- Jan 31, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Turbidimetric Method, Lipoproteins
- Device Class
- Class I
- Regulation Number
- 862.1475
- Review Panel
- CH
- Submission Type
- 510(k) Exempt