Susceptibility Test Powders, Antimicrobial
Susceptibility Test Powders, Antimicrobial are accurately weighed or quantified antimicrobial agent powders used to prepare standardized stock solutions for broth microdilution or agar dilution susceptibility testing, allowing determination of minimum inhibitory concentrations (MICs) for bacterial isolates. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is JTT, regulated under 21 CFR 866.1640, and falls within the Microbiology medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- JTT
- 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 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K983310 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN | Dec 17, 1998 | Substantially Equivalent | Accumed Intl., Inc. |
| K935805 | PASCO MIC AND MIC/ID PANELS | Jun 13, 1994 | Substantially Equivalent | Pasco Laboratories, Inc. |
| K895362 | BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST | Dec 01, 1989 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K880574 | MODIFIED IMIPENEM SUSCEPTIBILITY POWDER | May 04, 1988 | Substantially Equivalent | Merck, Sharp & Dohme |
| K872081 | CIPRO (TM) DIAGNOSTIC POWDER | Jun 15, 1987 | Substantially Equivalent | Miles Pharmaceuticals |
| K864442 | NORFLOXACIN SUSCEPTIBILITY POWDER | Dec 11, 1986 | Substantially Equivalent | Merck, Sharp & Dohme |
| K860031 | GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK | Mar 06, 1986 | Substantially Equivalent | Organon Teknika Corp. |
| K855207 | IMIPENEM 10 MCG SENSITIVITY DISCS | Mar 06, 1986 | Substantially Equivalent | Difco Laboratories, Inc. |
| K855106 | IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645 | Mar 06, 1986 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K855071 | IMIPENEM SUSCEPTIBILITY POWDER | Mar 06, 1986 | Substantially Equivalent | Merck, Sharp & Dohme |
| K830758 | AZLIN AZLOCILIN SODIUM-DIAG. REAGENT | May 25, 1983 | Substantially Equivalent | Miles Laboratories, Inc. |
| K822866 | MOXALACTAM | Dec 28, 1982 | Substantially Equivalent | Lilly Research Laboratories |
| K822329 | ANTITUBERCULOUS DRUGS (SIRE) | Sep 02, 1982 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K820578 | MEZLIN DIAGNOSTIC REAGENT | May 12, 1982 | Substantially Equivalent | Miles Pharmaceuticals |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.