510(k) K890577
K890577 is an FDA 510(k) premarket notification submitted by Kenlor Industries, Inc. for the device "KENLOR LIQUID URINE CONTROL". The FDA issued a decision of Substantially Equivalent on Mar 9, 1989. The device falls under product code JJW (Urinalysis Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Kenlor Industries, Inc. has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 9, 1989
- Date Received
- Feb 6, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Urinalysis Controls (Assayed And Unassayed)
- Device Class
- Class I
- Regulation Number
- 862.1660
- Review Panel
- CH
- Submission Type
- 510(k) Exempt