510(k) K870351
K870351 is an FDA 510(k) premarket notification submitted by Diamedix Corp. for the device "EZ COMPLEMENT REAGENTS, 78N2212". The FDA issued a decision of Substantially Equivalent on March 13, 1987. The device falls under product code DHL (Protein, Complement, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.4100. Diamedix Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 1987
- Date Received
- January 29, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Protein, Complement, Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.4100
- Review Panel
- IM
- Submission Type