DTM AGAR
FDA 510(k) clearance K844514 · decided 1985-01-07
Clearance details
- K-number
- K844514
- Device name
- DTM AGAR
- 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
- JSH
- 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 |
|---|---|---|
| DNASE TEST AGAR (K881486) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| UREA AGAR BASE (K881559) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| RUSSELL DOUBLE SUGAR AGAR (K881553) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| UREA BROTH (K881560) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| PHENOL RED BROTH BASE (K881551) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| FLO AGAR (K881540) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| MOELLERS DECARBOXYLASE, BASE (K880121) | Hardy Media | 1988-03-31 |
| OF MEDIUM BASE (K880117) | Hardy Media | 1988-03-30 |
| ACTINOMYCETE DIFFERENTIAL MEDIA (K873270) | Central Media | 1987-11-04 |
| MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA (K873263) | Central Media | 1987-10-28 |
| SIMMONS CITRATE MEDIUM SLANT, PRODUCT #T3084 (K873411) | Lakewood Biochemical Co., Inc. | 1987-10-06 |
| MOTILITY INDOLE ORNATHINE (MIO) PRODUCT #T3053 (K873704) | Lakewood Biochemical Co., Inc. | 1987-10-02 |
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 |