JSI · Culture Media, Selective And Differential
Microbiology · 21 CFR 866.2360 · Class 1
Overview
| Product Code | JSI |
|---|---|
| Device Name | Culture Media, Selective And Differential |
| Regulation | 21 CFR 866.2360 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
A selective culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate and identify certain pathogenic microorganisms. The device contains one or more components that suppress the growth of certain microorganisms while either promoting or not affecting the growth of other microorganisms. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.
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 285)
Showing 20 most recent of 285 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K070691 | BBL CHROMAGAR 0157 | Becton, Dickinson & CO | Nov 20, 2007 | SESE |
| K974428 | DIPSTREAK | Novamed , Ltd. | Jul 30, 1998 | SESE |
| K891593 | LISTERIA SELECTIVE ENRICHMENT MEDIUM | Oxoid U.S.A., Inc. | Jun 9, 1989 | SESE |
| K890199 | DENTOCULT SM-STRIP MUTANS | Orion Corp. | Mar 2, 1989 | SESE |
| K882182 | SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326 | Lakewood Biochemical Co., Inc. | Jun 6, 1988 | SESE |
| K881577 | MODIFIED SELECTIVE STREPTOCOCCUS AGAR | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881576 | SELENITE BROTH | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881575 | SELECTIVE STREPTOCOCCUS AGAR | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881572 | XL AGAR BASE | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881556 | TRICHOMONAS BROTH | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881555 | TINSDALE AGAR BASE | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K880125 | LOWENSTEIN-JENSEN, SELECTIVE | Hardy Media | Mar 31, 1988 | SESE |
| K880132 | DERMATOPHYTE TEST MEDIUM | Hardy Media | Mar 30, 1988 | SESE |
| K880130 | ATS MEDIA | Hardy Media | Mar 30, 1988 | SESE |
| K880108 | CORN MEAL W/POLYSORBATE 80 | Hardy Media | Mar 30, 1988 | SESE |
| K874344 | QUAD PLATE (4 DIFFERENT MEDIA) | Lakewood Biochemical Co., Inc. | Nov 6, 1987 | SESE |
| K873260 | CORYNEBACTERIA ISOLATION MEDIA | Central Media | Nov 6, 1987 | SESE |
| K873259 | SPECIALTY MEDIA | Central Media | Nov 6, 1987 | SESE |
| K873258 | STREPTOCOCCAL SELECTIVE DIFFEREN. & ENRICHED MEDIA | Central Media | Nov 6, 1987 | SESE |
| K873269 | MYCOLOGICAL MEDIA | Central Media | Nov 4, 1987 | SESE |
Top Applicants
- Acumedia Manufacturers, Inc. — 40 clearances
- Otisville Biotech, Inc. — 20 clearances
- Hardy Media — 17 clearances
- Isle Media and Sterile Products, Inc. — 15 clearances
- Lakewood Biochemical Co., Inc. — 14 clearances
