510(k) K831398
K831398 is an FDA 510(k) premarket notification submitted by Simmler, Inc. for the device "LINEAR ENZMATIC URIC ACID SYSTEM". The FDA issued a decision of Substantially Equivalent on Jun 8, 1983. The device falls under product code KNK (Acid, Uric, Uricase (Colorimetric)), a Class I device regulated under 21 CFR 862.1775. Simmler, Inc. has 22 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 8, 1983
- Date Received
- Apr 29, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid, Uric, Uricase (Colorimetric)
- Device Class
- Class I
- Regulation Number
- 862.1775
- Review Panel
- CH
- Submission Type
- 510(k) Exempt