510(k) K873565
K873565 is an FDA 510(k) premarket notification submitted by Molecular Biosystems, Inc. for the device "SNAP(R) ROTAVIRUS DIAGNOSTIC KIT". The FDA issued a decision of Substantially Equivalent on May 13, 1988. The device falls under product code LIO (Device, Specimen Collection), a Class I device regulated under 21 CFR 866.2900. Molecular Biosystems, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 1988
- Date Received
- September 2, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Specimen Collection
- Device Class
- Class I
- Regulation Number
- 866.2900
- Review Panel
- MI
- Submission Type