PHENOL RED BROTH W/CARBOHYDRATES
FDA 510(k) clearance K844539 · decided 1985-01-07
Clearance details
- K-number
- K844539
- Device name
- PHENOL RED BROTH W/CARBOHYDRATES
- 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
- JSF
- Device class
- 1
- Regulation number
- 866.2320
- 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 |
|---|---|---|
| NUTRIENT GELATIN - PRODUCT NUMBER T2860 (K880946) | Lakewood Biochemical Co., Inc. | 1988-04-01 |
| LAURYL TRYPTOSE BROTH (K880126) | Hardy Media | 1988-03-31 |
| MOELLERS DECARBOXYLASE, LYSINE (K880120) | Hardy Media | 1988-03-31 |
| MOELLERS DECARBOXYLASE, ONITHINE (K880119) | Hardy Media | 1988-03-31 |
| CYSTINE TRYPTIC MEDIUM W/ MALTOSE (K880112) | Hardy Media | 1988-03-30 |
| CYSTINE TRYPTIC MEDIUM W/LACTOSE (K880113) | Hardy Media | 1988-03-30 |
| MOELLOERS DECARBOXYLASE, ARGININE (K880118) | Hardy Media | 1988-03-30 |
| CYSTINE TRYPTIC MEDIUM W/DEXTROSE (K880110) | Hardy Media | 1988-03-30 |
| NITRATE BROTH (K880135) | Hardy Media | 1988-03-30 |
| BRILLIANT GREEN BILE BROTH (K880129) | Hardy Media | 1988-03-30 |
| ACETAMIDE AGAR SLANT (K880106) | Hardy Media | 1988-03-30 |
| CYSTINE TRYPTIC MEDIUM W/SUCROSE (K880111) | Hardy Media | 1988-03-30 |
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 |