JSD · Culture Media, Selective Broth
Microbiology · 21 CFR 866.2360 · Class 1
Overview
| Product Code | JSD |
|---|---|
| Device Name | Culture Media, Selective Broth |
| 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 26)
Showing 20 most recent of 26 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K883075 | FASTIDIOUS INOCULUM BROTH | Baxter Healthcare Corp | Aug 15, 1988 | SESE |
| K880107 | CAMPY BROTH | Hardy Media | Mar 30, 1988 | SESE |
| K873324 | SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331 | Lakewood Biochemical Co., Inc. | Oct 2, 1987 | SESE |
| K873218 | BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802 | Lakewood Biochemical Co., Inc. | Sep 23, 1987 | SESE |
| K871640 | ALKALINE PEPTONE WATER | Bd Becton Dickinson Vacutainer Systems Preanalytic | May 13, 1987 | SESE |
| K871447 | TODD HEWITT W/CNA (LIM BROTH) | Remel Co. | May 13, 1987 | SESE |
| K870594 | T9802 TSB W/6.5% NACL | Lakewood Biochemical Co., Inc. | Mar 30, 1987 | SESE |
| K853609 | APL TRYPTIC SOY BROTH | Apl Medical Supplies | Sep 12, 1985 | SESE |
| K844547 | TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE | bioMerieux, Inc. | Jan 16, 1985 | SESE |
| K841836 | SELECTIVE CULTURE MED. TRICHOMONAS | Microline Scientific | May 14, 1984 | SESE |
| K840971 | SELECTIVE CULTURE MEDIUM | Chatham Biological | Apr 13, 1984 | SESE |
| K841211 | SELECTIVE BROTH | Smith River Biologicals | Apr 5, 1984 | SESE |
| K834013 | SF BROTH | Micro Media Laboratories | Dec 27, 1983 | SESE |
| K834015 | SELENITE BROTH | Micro Media Laboratories | Dec 22, 1983 | SESE |
| K833759 | GROUP STREP BROTH T3472 LIM | Gibco Laboratories Life Technologies, Inc. | Dec 16, 1983 | SESE |
| K832310 | ROGOSA BROTH | Oxoid U.S.A., Inc. | Sep 1, 1983 | SESE |
| K822330 | BACTEC DILUTING FLUID | Bd Becton Dickinson Vacutainer Systems Preanalytic | Sep 2, 1982 | SESE |
| K822131 | DERMATOPHYTE TEST MEDIUM | Granite Diagnostics, Inc. | Aug 3, 1982 | SESE |
| K820843 | CULTURE MEDIA SELECTIVE BROTH | Blue Ridge Media Co. | Apr 16, 1982 | SESE |
| K820558 | SELENITE BROTH | American Laboratory Supply, Inc. | Mar 16, 1982 | SESE |
Top Applicants
- Isle Media and Sterile Products, Inc. — 4 clearances
- Lakewood Biochemical Co., Inc. — 3 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 2 clearances
- Granite Diagnostics, Inc. — 2 clearances
- Micro Media Laboratories — 2 clearances
