510(k) K901124
K901124 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "CHEM I CLINICAL ANALYZER URINE MAGNESIUM". The FDA issued a decision of Substantially Equivalent on May 14, 1990. The device falls under product code JGJ (Photometric Method, Magnesium), a Class I device regulated under 21 CFR 862.1495. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 1990
- Date Received
- March 12, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Photometric Method, Magnesium
- Device Class
- Class I
- Regulation Number
- 862.1495
- Review Panel
- CH
- Submission Type