510(k) K842541
K842541 is an FDA 510(k) premarket notification submitted by Clinical Sciences, Inc. for the device "RAPID PLASMA REAGIN CARD TEST". The FDA issued a decision of Substantially Equivalent on July 26, 1984. The device falls under product code GMQ (Antigens, Nontreponemal, All), a Class II device regulated under 21 CFR 866.3820. Clinical Sciences, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 1984
- Date Received
- July 2, 1984
- 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