510(k) K864228
K864228 is an FDA 510(k) premarket notification submitted by Intl. Diagnostic Laboratories, Ltd. for the device "APO B., IMMUNOTURBIDIMETRIC ASSAY". The FDA issued a decision of Substantially Equivalent on March 12, 1987. The device falls under product code MSJ (Apolipoproteins), a Class I device regulated under 21 CFR 862.1475. Intl. Diagnostic Laboratories, Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 1987
- Date Received
- October 28, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apolipoproteins
- Device Class
- Class I
- Regulation Number
- 862.1475
- Review Panel
- CH
- Submission Type