510(k) K862806
K862806 is an FDA 510(k) premarket notification submitted by Amatech International, Inc. for the device "URINE DIAGNOSTIC REAGENT STRIPS". The FDA issued a decision of Substantially Equivalent on December 4, 1986. The device falls under product code JJB (Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1115. Amatech International, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 1986
- Date Received
- July 23, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- Device Class
- Class I
- Regulation Number
- 862.1115
- Review Panel
- CH
- Submission Type