510(k) K020689
- Device
- SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM
- Applicant
- Midi, Inc.
- 510(k) number
- K020689
- Product code
- NJO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-10-31
- Date received
- 2002-03-04
- Regulation
- 866.3370
- Classification name
- System, Mycolic Acid Analysis, Mycobacterium Tuberculosis
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- WILLIAMS STIMSON
- Address
- 125 Sandy Dr. Newark DE US 19713 19713
Source Documents#
510(k) summary PDF not indicated by FDA