JSK · Supplement, Culture Media
Microbiology · 21 CFR 866.2450 · Class 1
Overview
| Product Code | JSK |
|---|---|
| Device Name | Supplement, Culture Media |
| Regulation | 21 CFR 866.2450 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
A supplement for culture media is a device, such as a vitamin or sugar mixture, that is added to a solid or liquid basal culture medium to produce a desired formulation and that is intended for medical purposes to enhance the growth of fastidious microorganisms (those having complex nutritional requirements). This device aids in the diagnosis of diseases caused by pathogenic microorganisms.
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 70)
Showing 20 most recent of 70 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K881949 | ATS NAC-PAC SET | Alpha-Tec Systems, Inc. | May 25, 1988 | SESE |
| K881879 | ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 | Alpha-Tec Systems, Inc. | May 13, 1988 | SESE |
| K881566 | HEMOGLOBIN POWDER | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K861997 | PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE | Hazleton Research Products, Inc. | Jun 10, 1986 | SESE |
| K861824 | GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) | Flow Laboratories, Inc. | May 20, 1986 | SESE |
| K861823 | GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) | Flow Laboratories, Inc. | May 20, 1986 | SESE |
| K861791 | PENICILLIN-STREPTOMYCIN-FUNGIZONE | Flow Laboratories, Inc. | May 20, 1986 | SESE |
| K855172 | KWI (TM) G-CO/TWO | Micro-Bio-Logics | Feb 20, 1986 | SESE |
| K853546 | ABBOTT CATION SUPPLEMENT SOLUTION | Abbott Laboratories | Sep 6, 1985 | SESE |
| K850302 | SUPLEX & SUPLEX DILUENT | Pro-Lab, Inc. | Mar 22, 1985 | SESE |
| K850738 | SUPPLEMENT FOR CULTURE MEDIUM | Roseville Medical Laboratoriesu | Mar 20, 1985 | SESE |
| K850308 | C.L.A.T. | Pro-Lab, Inc. | Mar 20, 1985 | SESE |
| K850307 | CAMPYLOBACTER SUPPLEMENT-BLASER/WANG | Pro-Lab, Inc. | Mar 20, 1985 | SESE |
| K850306 | CAMPYLOBACTER SUPPLEMENT -SKIRROW | Pro-Lab, Inc. | Mar 20, 1985 | SESE |
| K850301 | YEAST DIALYSATE | Pro-Lab, Inc. | Mar 20, 1985 | SESE |
| K850300 | MUCOLYSE | Pro-Lab, Inc. | Mar 20, 1985 | SESE |
| K850299 | C.N.V.T. | Pro-Lab, Inc. | Mar 20, 1985 | SESE |
| K840333 | LEGIONELLA BMPA SELECTIVE SUPPLE | Oxoid U.S.A., Inc. | May 11, 1984 | SESE |
| K840331 | LEGIONELLA MWY SELECTIVE SUPPLEMENT | Oxoid U.S.A., Inc. | May 11, 1984 | SESE |
| K840330 | PRESTON CAMPYLOBACTER SELECTIVE SUPP | Oxoid U.S.A., Inc. | May 11, 1984 | SESE |
Top Applicants
- Oxoid U.S.A., Inc. — 30 clearances
- Acumedia Manufacturers, Inc. — 10 clearances
- Gibco Laboratories Life Technologies, Inc. — 7 clearances
- Pro-Lab, Inc. — 7 clearances
- Flow Laboratories, Inc. — 3 clearances
