510(k) K030873
K030873 is an FDA 510(k) premarket notification submitted by Randox Laboratories, Ltd. for the device "RANDOX AMMONIA". The FDA issued a decision of Substantially Equivalent on May 12, 2003. The device falls under product code JIF (Enzymatic Method, Ammonia), a Class I device regulated under 21 CFR 862.1065. Randox Laboratories, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 12, 2003
- Date Received
- March 20, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzymatic Method, Ammonia
- Device Class
- Class I
- Regulation Number
- 862.1065
- Review Panel
- CH
- Submission Type