510(k) K843359
K843359 is an FDA 510(k) premarket notification submitted by Applied Polytechnology, Inc. for the device "URINE TRANSPORT KIT". The FDA issued a decision of Substantially Equivalent on September 27, 1984. The device falls under product code JTW (System, Transport, Aerobic), a Class I device regulated under 21 CFR 866.2900. Applied Polytechnology, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1984
- Date Received
- August 27, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Transport, Aerobic
- Device Class
- Class I
- Regulation Number
- 866.2900
- Review Panel
- MI
- Submission Type