Monitor, Microbial Growth
Monitor, Microbial Growth is a laboratory instrument used to detect and monitor the growth of microorganisms in culture media or specimens, typically through optical or other physical measurement methods, supporting microbiological analysis and quality control. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JTA, regulated under 21 CFR 866.2560, and falls within the Microbiology medical specialty.
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Basic Information
- Product Code
- JTA
- Device Class
- FDA class 1
- Regulation Number
- 866.2560
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K954923 | BACTEC FUNGAL MEDIUM | Nov 21, 1996 | Substantially Equivalent | Becton Dickinson Diagnostic Instrument Systems |
| K910835 | BACTEC NR-860 | Mar 11, 1991 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K865021 | BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM | Feb 06, 1987 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K853011 | BACTEC NR-730 BACTERIAL DETECTION SYSTEM | Jul 30, 1985 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K842874 | RADIOMETRIC BLOOD CULTURE VIALS, AEROBE | Sep 12, 1984 | Substantially Equivalent | American Micro Scan |
| K842279 | BECTEC NR-660 BACTERIAL DETECT SYS | Jul 20, 1984 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K834264 | REVERSE-FLOW SYSTEM | Jan 13, 1984 | Substantially Equivalent | Applied Polytechnology, Inc. |
| K833917 | BAC-T-SCREEN | Jan 13, 1984 | Substantially Equivalent | Marion Laboratories, Inc. |
| K810042 | BACTEC BACTERIAL DETECTION SYSTEM: #5 | Jan 28, 1981 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K792575 | BACTEC BACTERIAL DETECTION SYSTEM | Dec 27, 1979 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K790297 | DETECTION SYSTEM, MS-2 ELECTROCHEMICAL | Apr 26, 1979 | Substantially Equivalent | Abbott Laboratories |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.