510(k) K903338
K903338 is an FDA 510(k) premarket notification submitted by Kenlor Industries, Inc. for the device "KENLOR THERAPEUTIC DRUG MONITORING (TDM) CONTROL". The FDA issued a decision of Substantially Equivalent on Sep 7, 1990. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), 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
- Sep 7, 1990
- Date Received
- Jul 25, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Multi-Analyte Controls, All Kinds (Assayed)
- Device Class
- Class I
- Regulation Number
- 862.1660
- Review Panel
- CH
- Submission Type
- 510(k) Exempt