JSC · Culture Media, General Nutrient Broth
Microbiology · 21 CFR 866.2350 · Class 1
Overview
| Product Code | JSC |
|---|---|
| Device Name | Culture Media, General Nutrient Broth |
| 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 (20 of 52)
Showing 20 most recent of 52 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K850143 | SPORDEX CULTURE MEDIA | American Sterilizer Co. | Mar 5, 1985 | SESE |
| K842852 | BRAIN HEART INFUSION BROTH | Anarobe Systems | Aug 3, 1984 | SESE |
| K842849 | TRYPTICASE SOY BROTH | Anarobe Systems | Aug 3, 1984 | SESE |
| K841221 | BRAIN HEART INFUSION BROTH | Anaerobe Systems | Apr 4, 1984 | SESE |
| K841219 | SHOPPED MEAT CARBOHYDRATE | Anaerobe Systems | Apr 4, 1984 | SESE |
| K833300 | SABOURAUD BHI AGAR | Acumedia Manufacturers, Inc. | Nov 7, 1983 | SESE |
| K832620 | TRYPTIC SOY BROTH MEDIA | Carroll Biological Corp. | Sep 12, 1983 | SESE |
| K832619 | THIOGLYCOLLATE MEDIUM | Carroll Biological Corp. | Sep 12, 1983 | SESE |
| K832570 | EXTRACT BROTH | Acumedia Manufacturers, Inc. | Sep 12, 1983 | SESE |
| K832569 | INFUSION BROTH | Acumedia Manufacturers, Inc. | Sep 12, 1983 | SESE |
| K830437 | CHS | Dms Laboratories | Mar 17, 1983 | SESE |
| K822665 | WILKINS-CHALGREN ANAEROBE BROTH | Oxoid U.S.A., Inc. | Sep 21, 1982 | SESE |
| K822487 | MINITEK GRAM-POSITIVE BROTH & SET AND | Bd Becton Dickinson Vacutainer Systems Preanalytic | Sep 21, 1982 | SESE |
| K821864 | THIOGLYCOLLATE MED. W/VITAMIN K-1 | Granite Diagnostics, Inc. | Jul 13, 1982 | SESE |
| K821597 | BRAIN HEART INFUSION | Hardy Media | Jul 8, 1982 | SESE |
| K821610 | THIOGLYCOLATE WITHOUT INDICATOR | Hardy Media | Jul 6, 1982 | SESE |
| K821601 | TRYPTIC SOY AGAR | Hardy Media | Jul 6, 1982 | SESE |
| K821600 | TRYPTIC SOY BROTH | Hardy Media | Jul 6, 1982 | SESE |
| K821598 | FLUID THIOGLYCOLLATE BROTH | Hardy Media | Jul 6, 1982 | SESE |
| K820840 | CULTURE MEDIA, GENERAL NUTRIENT BROTH | Blue Ridge Media Co. | Apr 16, 1982 | SESE |
Top Applicants
- Acumedia Manufacturers, Inc. — 6 clearances
- Anaerobe Systems — 6 clearances
- Isle Media and Sterile Products, Inc. — 6 clearances
- Hardy Media — 5 clearances
- Abbott Laboratories — 4 clearances
