JSJ · Culture Media, Selective And Non-Differential
Microbiology · 21 CFR 866.2360 · Class 1
Overview
| Product Code | JSJ |
|---|---|
| Device Name | Culture Media, Selective And Non-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 307)
Showing 20 most recent of 307 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K882463 | POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 | Lakewood Biochemical Co., Inc. | Jun 22, 1988 | SESE |
| K881578 | STREPTOSEL | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881574 | W-L DIFFERENTIAL MEDIUM | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881573 | PHYTONE YEAST EXTRACT AGAR | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881571 | YM BROTH | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881570 | SABOURAUD MALTOSE AGAR | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881565 | INHIBITORY MOLD AGAR | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881561 | TERGITOL 7 BROTH | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881549 | MYCOLOGICAL AGAR W/LOW PH | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881547 | MITIS SALIVARIUS AGAR | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881544 | LITTMAN AGAR | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881530 | BRILLIANT GREEN AGAR W/SULFADIAZINE | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881526 | CHAPMAN STONE MEDIUM | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K881524 | DERMATOPHYTE TEST MEDIUM | Acumedia Manufacturers, Inc. | Apr 18, 1988 | SESE |
| K880124 | LOWENSTEIN-JENSEN, W/NACL | Hardy Media | Mar 31, 1988 | SESE |
| K880123 | LOWENSTEIN-JENSEN SLANT | Hardy Media | Mar 31, 1988 | SESE |
| K880945 | CAMPLYOBACTER CULTURE MEDIA PRODUCTS P3873/T3597 | Lakewood Biochemical Co., Inc. | Mar 30, 1988 | SESE |
| K880141 | BCYE, SELECTIVE (W/MPA) | Hardy Media | Mar 30, 1988 | SESE |
| K880140 | BCYE AGAR | Hardy Media | Mar 30, 1988 | SESE |
| K880137 | BHI WITH C & C SLANT | Hardy Media | Mar 30, 1988 | SESE |
Top Applicants
- Acumedia Manufacturers, Inc. — 30 clearances
- Lakewood Biochemical Co., Inc. — 30 clearances
- Hardy Media — 26 clearances
- Otisville Biotech, Inc. — 23 clearances
- Gibco Laboratories Life Technologies, Inc. — 18 clearances
