510(k) K854523
K854523 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "ANALYST PHYSICIAN'S OFFICE PROFILER". The FDA issued a decision of Substantially Equivalent on January 8, 1986. The device falls under product code JJG (Analyzer, Chemistry, Centrifugal, For Clinical Use), a Class I device regulated under 21 CFR 862.2140. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 8, 1986
- Date Received
- November 12, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Chemistry, Centrifugal, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2140
- Review Panel
- CH
- Submission Type