510(k) K013368
- Device
- HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
- Applicant
- TREK DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K013368
- Product code
- LTT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-11-20
- Date received
- 2001-10-11
- Regulation
- 866.1640
- Classification name
- Panels, Test, Susceptibility, Antimicrobial
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CYNTHIA C KNAPP
- Address
- 29299 Clemens Rd. Suite 1-K Westlake OH US 44145 44145
FDA Registration Numbers#
- 3013718871
- 1950204
- 3003750284
- 1119779
- 3013661582
- 1924669
- 3009637528
- 3012389632
- 3031977134
- 2919016
- 1530126
- 8021914
- 3009171251
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases