510(k) K896440
K896440 is an FDA 510(k) premarket notification submitted by Kenlor Industries, Inc. for the device "KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT". The FDA issued a decision of Substantially Equivalent on Feb 16, 1990. The device falls under product code JIR (Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1645. Kenlor Industries, Inc. has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 16, 1990
- Date Received
- Nov 9, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- Device Class
- Class I
- Regulation Number
- 862.1645
- Review Panel
- CH
- Submission Type
- 510(k) Exempt