The following data is part of a premarket notification filed by Idaho Technology, Inc. with the FDA for Modification To Jbaids Anthrax Detection System.
| Device ID | K071188 |
| 510k Number | K071188 |
| Device Name: | MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-30 |
| Decision Date | 2007-05-21 |
| Summary: | summary |