510(k) K822709
K822709 is an FDA 510(k) premarket notification submitted by Laprol Scientific, Inc. for the device "URITEST 9, INLAB REAGENT STRIPS URINALY". The FDA issued a decision of Substantially Equivalent on January 28, 1983. The device falls under product code JMA (Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)), a Class I device regulated under 21 CFR 862.1095. Laprol Scientific, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 1983
- Date Received
- September 7, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
- Device Class
- Class I
- Regulation Number
- 862.1095
- Review Panel
- CH
- Submission Type