510(k) K851377
K851377 is an FDA 510(k) premarket notification submitted by Diagnon Corp. for the device "DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA". The FDA issued a decision of Substantially Equivalent on August 21, 1985. The device falls under product code CDD (Radioassay, Vitamin B12), a Class II device regulated under 21 CFR 862.1810. Diagnon Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 1985
- Date Received
- April 8, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioassay, Vitamin B12
- Device Class
- Class II
- Regulation Number
- 862.1810
- Review Panel
- CH
- Submission Type