JSA · Culture Media, Antibiotic Assay
Microbiology · 21 CFR 866.2350 · Class 1
Overview
| Product Code | JSA |
|---|---|
| Device Name | Culture Media, Antibiotic Assay |
| Regulation | 21 CFR 866.2350 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
A microbiological assay culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate selected test microorganisms in order to measure by microbiological procedures the concentration in a patient's serum of certain substances, such as amino acids, antimicrobial agents, and vitamins. The concentration of these substances is measured by their ability to promote or inhibit the growth of the test organism in the innoculated medium. Test results aid in the diagnosis of disease resulting from either deficient or excessive amounts of these substances in a patient's serum. Tests results may also be used to monitor the effects of the administration of certain antimicrobial drugs.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K881538 | ANTIBIOTIC MEDIUM #10 POLYMYXIN SEED AGAR | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881537 | ANTIBIOTIC MEDIUM #19 | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881536 | ANTIBIOTIC MEDIUM #5 STREPTOMYCIN ASSAY AGAR | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881535 | ANTIBIOTIC MEDIUM #6 | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881534 | ANTIBIOTIC MEDIUM #9 POLYMYXIN BASE AGAR | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K832577 | SEED AGAR | Acumedia Manufacturers, Inc. | Sep 12, 1983 | SESE |
| K832576 | BASE AGAR | Acumedia Manufacturers, Inc. | Sep 12, 1983 | SESE |
| K832575 | ANTIBIOTIC ASSAY BROTH | Acumedia Manufacturers, Inc. | Sep 12, 1983 | SESE |
Top Applicants
- Acumedia Manufacturers, Inc. — 8 clearances
