TRICHOMONAS BROTH
FDA 510(k) clearance K844533 · decided 1985-01-07
Clearance details
- K-number
- K844533
- Device name
- TRICHOMONAS BROTH
- Applicant
- bioMerieux, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-11-21
- Decision date
- 1985-01-07
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- JSJ
- Device class
- 1
- Regulation number
- 866.2360
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Addison, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (K882463) | Lakewood Biochemical Co., Inc. | 1988-06-22 |
| SABOURAUD MALTOSE AGAR (K881570) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| YM BROTH (K881571) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| MYCOLOGICAL AGAR W/LOW PH (K881549) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| CHAPMAN STONE MEDIUM (K881526) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| PHYTONE YEAST EXTRACT AGAR (K881573) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| STREPTOSEL (K881578) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| BRILLIANT GREEN AGAR W/SULFADIAZINE (K881530) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| INHIBITORY MOLD AGAR (K881565) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| MITIS SALIVARIUS AGAR (K881547) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| TERGITOL 7 BROTH (K881561) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| LITTMAN AGAR (K881544) | Acumedia Manufacturers, Inc. | 1988-04-18 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| THXID-BRAF (P120014/S012) | bioMerieux, Inc. | 2021-12-20 |
| THxID-BRAF kit (P120014/S011) | bioMerieux, Inc. | 2021-03-10 |
| THxID-BRAF assay kit (P120014/S010) | bioMerieux, Inc. | 2020-02-26 |
| THxID BRAF assay kit (P120014/S009) | bioMerieux, Inc. | 2019-08-26 |
| THxID BRAF assay kit (P120014/S008) | bioMerieux, Inc. | 2018-06-27 |
| THxID-BRAF kit (P120014/S007) | bioMerieux, Inc. | 2016-11-22 |
| VIDAS TOTAL PSA (P040008/S013) | bioMerieux, Inc. | 2016-05-31 |
| THXID-BRAF KIT (P120014/S006) | bioMerieux, Inc. | 2016-04-05 |