510(k) K900743
K900743 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "CMV-IGM IFA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on April 26, 1990. The device falls under product code LKQ (Antibody Igm,If, Cytomegalovirus Virus), a Class II device regulated under 21 CFR 866.3175. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 26, 1990
- Date Received
- February 16, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antibody Igm,If, Cytomegalovirus Virus
- Device Class
- Class II
- Regulation Number
- 866.3175
- Review Panel
- MI
- Submission Type