510(k) K923036
K923036 is an FDA 510(k) premarket notification submitted by Heraeus Kulzer, Inc. for the device "URINE CHLORIDE". The FDA issued a decision of Substantially Equivalent on September 9, 1992. The device falls under product code CHJ (Mercuric Thiocyanate, Colorimetry, Chloride), a Class II device regulated under 21 CFR 862.1170. Heraeus Kulzer, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 1992
- Date Received
- June 19, 1992
- 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