510(k) K921495
K921495 is an FDA 510(k) premarket notification submitted by Symcon Intl., Inc. for the device "DIA STRIPS SYSTEM, MODIFIED". The FDA issued a decision of Substantially Equivalent on Jul 21, 1992. The device falls under product code JIO (Blood, Occult, Colorimetric, In Urine), a Class II device regulated under 21 CFR 864.6550.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 21, 1992
- Date Received
- Mar 6, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Blood, Occult, Colorimetric, In Urine
- Device Class
- Class II
- Regulation Number
- 864.6550
- Review Panel
- HE
- Submission Type