The following data is part of a premarket notification filed by Idaho Technology, Inc. with the FDA for Jbaids Anthrac Detection System.
Device ID | K051713 |
510k Number | K051713 |
Device Name: | JBAIDS ANTHRAC 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 | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-06-27 |
Decision Date | 2005-11-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00851458005006 | K051713 | 000 |