510(k) K884013
K884013 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ROCHE REAGENT FOR CHLORIDE". The FDA issued a decision of Substantially Equivalent on December 9, 1988. The device falls under product code CHJ (Mercuric Thiocyanate, Colorimetry, Chloride), a Class II device regulated under 21 CFR 862.1170. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 1988
- Date Received
- September 22, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mercuric Thiocyanate, Colorimetry, Chloride
- Device Class
- Class II
- Regulation Number
- 862.1170
- Review Panel
- CH
- Submission Type