510(k) K852418
K852418 is an FDA 510(k) premarket notification submitted by Amf Biological And Diagnostics Co. for the device "QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL)". The FDA issued a decision of Substantially Equivalent on Jul 15, 1985. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Amf Biological And Diagnostics Co. has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 15, 1985
- Date Received
- Jun 7, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Multi-Analyte Controls, All Kinds (Assayed)
- Device Class
- Class I
- Regulation Number
- 862.1660
- Review Panel
- CH
- Submission Type
- 510(k) Exempt