JSG · Culture Media, Non-Selective And Non-Differential
Microbiology · 21 CFR 866.2300 · Class 1
Overview
| Product Code | JSG |
|---|---|
| Device Name | Culture Media, Non-Selective And Non-Differential |
| Regulation | 21 CFR 866.2300 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
A multipurpose culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes for the cultivation and identification of several types of pathogenic microorganisms without the need of additional nutritional supplements. Test results aid in the diagnosis of disease and also provide epidemiological information on diseases caused by these 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 209)
Showing 20 most recent of 209 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K882495 | THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 | Lakewood Biochemical Co., Inc. | Jul 1, 1988 | SESE |
| K881564 | TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACT | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881563 | TRYPTOSE PHOSPHATE BROTH | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881562 | TRYPTOSE BLOOD AGAR BASE | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881558 | TRYPTOSE AGAR | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881557 | TRYPTONE | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881554 | SKIM MILK DEHYDRATED | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881550 | OF BASAL MEDIUM | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881548 | MPH AGAR | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881546 | MALT EXTRACT AGAR | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881545 | MALT EXTRACT | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881543 | LETHEEN AGAR | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881542 | HEART INFUSION AGAR | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881541 | GELATIN | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881533 | BLOOD AGAR BASE NO. 2 | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881532 | BLOOD AGAR BASE W/LOW PH | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881531 | BLOOD AGAR BASE, IMPROVED | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881528 | CASEIN PEPTONE, LOW VITAMIN | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881525 | COOKED MEAT MEDIUM | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881523 | DEXTROSE TRYPTONE BROTH | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
Top Applicants
- Acumedia Manufacturers, Inc. — 42 clearances
- Lakewood Biochemical Co., Inc. — 28 clearances
- Otisville Biotech, Inc. — 17 clearances
- Isle Media and Sterile Products, Inc. — 15 clearances
- Hardy Media — 13 clearances
