The following data is part of a premarket notification filed by Applied Polytechnology, Inc. with the FDA for Bacteriuria Detect. Device Aptek Ii.
Device ID | K843834 |
510k Number | K843834 |
Device Name: | BACTERIURIA DETECT. DEVICE APTEK II |
Classification | Kit, Screening, Urine |
Applicant | APPLIED POLYTECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Contact | Claude C Longoria |
Correspondent | Claude C Longoria APPLIED POLYTECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JXA |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-01 |
Decision Date | 1984-11-29 |