510(k) K874594
K874594 is an FDA 510(k) premarket notification submitted by Clinical Sciences, Inc. for the device "TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560". The FDA issued a decision of Substantially Equivalent on March 7, 1988. The device falls under product code LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Clinical Sciences, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 7, 1988
- Date Received
- November 9, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- Device Class
- Class II
- Regulation Number
- 866.3780
- Review Panel
- MI
- Submission Type