The following data is part of a premarket notification filed by Idaho Technology, Inc. with the FDA for Jbaids Plaque Detection Kit, Model Jrpd-asy-0123.
Device ID | K072631 |
510k Number | K072631 |
Device Name: | JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123 |
Classification | Assay, Nucleic Acid Amplification, Bacillus Anthracis |
Applicant | IDAHO TECHNOLOGY, INC. 390 Wakara Way Salt Lake City, UT 84108 |
Contact | Beth Lingenfelter |
Correspondent | Beth Lingenfelter IDAHO TECHNOLOGY, INC. 390 Wakara Way Salt Lake City, UT 84108 |
Product Code | NHT |
CFR Regulation Number | 866.3045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-18 |
Decision Date | 2007-12-20 |
Summary: | summary |