Susceptibility Test Cards, Antimicrobial
Antimicrobial Susceptibility Test Cards (product code LTW) are microbiology diagnostic devices used to assess the sensitivity of bacteria to various antibiotics, typically in automated identification systems. Regulated under 21 CFR 866.1640, they are classified as a Class 2 device and require a 510(k) premarket notification. The device is eligible for third-party review under the Microbiology panel. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- LTW
- Device Class
- FDA class 2
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K852613 | MIC-CONCEPT SYSTEM | Sep 20, 1985 | Substantially Equivalent | Microtech Medical Systems, Inc. |
| K853772 | PRECEPT METHICILLIN | Sep 16, 1985 | Substantially Equivalent | Austin Biological Laboratories |
| K853685 | PRECEPT TM CARBENICILLIN | Sep 16, 1985 | Substantially Equivalent | Austin Biological Laboratories |
| K853596 | PRECEPT CEFOPERAZONE | Sep 16, 1985 | Substantially Equivalent | Austin Biological Laboratories |
| K853273 | PRECEPT CEFTRIAXONE | Sep 16, 1985 | Substantially Equivalent | Austin Biological Laboratories |
| K853689 | PRECEPT TM MOXALACTAM | Sep 13, 1985 | Substantially Equivalent | Austin Biological Laboratories |
| K853688 | PRECEPT TM TOBRAMYCIN | Sep 13, 1985 | Substantially Equivalent | Austin Biological Laboratories |
| K853687 | PRECEPT NETILMICIN 32-13 | Sep 13, 1985 | Substantially Equivalent | Austin Biological Laboratories |
| K853686 | PRECEPT TM AMIKACIN | Sep 13, 1985 | Substantially Equivalent | Austin Biological Laboratories |
| K853684 | PRECEPT KANAMYCIN | Sep 13, 1985 | Substantially Equivalent | Austin Biological Laboratories |
| K853263 | PRECEPT AVGMENTIN | Aug 29, 1985 | Substantially Equivalent | Austin Biological Laboratories |
| K853053 | PRECEPT ERYTHROMYCIN | Aug 29, 1985 | Substantially Equivalent | Austin Biological Laboratories |
| K850347 | API UNISCEPT KB | Mar 26, 1985 | Substantially Equivalent | Analytical Products, Inc. |
| K844159 | API UNISCEPT MIC 100UL | Dec 14, 1984 | Substantially Equivalent | Analytical Products, Inc. |
| K844231 | SCEPTOR BETA-LACTAM PLUS MIC PANEL | Nov 07, 1984 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K843733 | API UNISCEPT KB | Oct 24, 1984 | Substantially Equivalent | Analytical Products, Inc. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.