510(k) K874595
K874595 is an FDA 510(k) premarket notification submitted by Simmler, Inc. for the device "MULTICHEM (R) MAGNESIUM REAGENT". The FDA issued a decision of Substantially Equivalent on Jan 21, 1988. The device falls under product code JGJ (Photometric Method, Magnesium), a Class I device regulated under 21 CFR 862.1495. Simmler, Inc. has 22 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 21, 1988
- Date Received
- Nov 9, 1987
- 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
- 510(k)