510(k) K874544
K874544 is an FDA 510(k) premarket notification submitted by Molecular Biosystems, Inc. for the device "SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT". The FDA issued a decision of Substantially Equivalent on August 12, 1988. The device falls under product code LGO (Test, Leukocyte Typing), a Class I device regulated under 21 CFR 864.7675. Molecular Biosystems, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1988
- Date Received
- November 3, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Leukocyte Typing
- Device Class
- Class I
- Regulation Number
- 864.7675
- Review Panel
- HE
- Submission Type