510(k) K964715
K964715 is an FDA 510(k) premarket notification submitted by Dade Intl., Inc. for the device "PARAMAX SALICYLATE REAGENT". The FDA issued a decision of Substantially Equivalent on April 25, 1997. The device falls under product code DKJ (Colorimetry, Salicylate), a Class II device regulated under 21 CFR 862.3830. Dade Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 1997
- Date Received
- November 25, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colorimetry, Salicylate
- Device Class
- Class II
- Regulation Number
- 862.3830
- Review Panel
- TX
- Submission Type