510(k) K864731
K864731 is an FDA 510(k) premarket notification submitted by Ocean Scientific, Inc. for the device "OCEAN SCIENTIFIC VDRL TEST". The FDA issued a decision of Substantially Equivalent on March 10, 1987. The device falls under product code GMQ (Antigens, Nontreponemal, All), a Class II device regulated under 21 CFR 866.3820. Ocean Scientific, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 1987
- Date Received
- December 4, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigens, Nontreponemal, All
- Device Class
- Class II
- Regulation Number
- 866.3820
- Review Panel
- MI
- Submission Type