Culture Media, Antibiotic Assay
The Culture Media, Antibiotic Assay is a microbiology diagnostic medium used for the microbiological assay of antibiotic concentrations in biological specimens or pharmaceutical preparations, employing indicator microorganisms whose inhibited growth correlates with the concentration of the antibiotic under test. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JSA and is regulated under 21 CFR 866.2350, within the Microbiology medical specialty.
Basic Information
- Product Code
- JSA
- Device Class
- FDA class 1
- Regulation Number
- 866.2350
- 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 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K881538 | ANTIBIOTIC MEDIUM #10 POLYMYXIN SEED AGAR | Apr 18, 1988 | Substantially Equivalent | ACUMEDIA MANUFACTURERS, INC. |
| K881537 | ANTIBIOTIC MEDIUM #19 | Apr 18, 1988 | Substantially Equivalent | ACUMEDIA MANUFACTURERS, INC. |
| K881536 | ANTIBIOTIC MEDIUM #5 STREPTOMYCIN ASSAY AGAR | Apr 18, 1988 | Substantially Equivalent | ACUMEDIA MANUFACTURERS, INC. |
| K881535 | ANTIBIOTIC MEDIUM #6 | Apr 18, 1988 | Substantially Equivalent | ACUMEDIA MANUFACTURERS, INC. |
| K881534 | ANTIBIOTIC MEDIUM #9 POLYMYXIN BASE AGAR | Apr 18, 1988 | Substantially Equivalent | ACUMEDIA MANUFACTURERS, INC. |
| K832577 | SEED AGAR | Sep 12, 1983 | Substantially Equivalent | ACUMEDIA MANUFACTURERS, INC. |
| K832576 | BASE AGAR | Sep 12, 1983 | Substantially Equivalent | ACUMEDIA MANUFACTURERS, INC. |
| K832575 | ANTIBIOTIC ASSAY BROTH | Sep 12, 1983 | Substantially Equivalent | ACUMEDIA MANUFACTURERS, INC. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.