510(k) K843834
K843834 is an FDA 510(k) premarket notification submitted by Applied Polytechnology, Inc. for the device "BACTERIURIA DETECT. DEVICE APTEK II". The FDA issued a decision of Substantially Equivalent on November 29, 1984. The device falls under product code JXA (Kit, Screening, Urine), a Class I device regulated under 21 CFR 866.2660. Applied Polytechnology, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 1984
- Date Received
- October 1, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Screening, Urine
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type