MACCONKEY AGAR
FDA 510(k) clearance K830071 · decided 1983-02-09
Clearance details
- K-number
- K830071
- Device name
- MACCONKEY AGAR
- Applicant
- bioMerieux, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-01-11
- Decision date
- 1983-02-09
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- JSI
- Device class
- 1
- Regulation number
- 866.2360
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, 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 |
|---|---|---|
| BBL CHROMAGAR 0157 (K070691) | Becton, Dickinson & CO | 2007-11-20 |
| DIPSTREAK (K974428) | Novamed , Ltd. | 1998-07-30 |
| LISTERIA SELECTIVE ENRICHMENT MEDIUM (K891593) | Oxoid U.S.A., Inc. | 1989-06-09 |
| DENTOCULT SM-STRIP MUTANS (K890199) | Orion Corp. | 1989-03-02 |
| SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326 (K882182) | Lakewood Biochemical Co., Inc. | 1988-06-06 |
| TRICHOMONAS BROTH (K881556) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| XL AGAR BASE (K881572) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| SELENITE BROTH (K881576) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| MODIFIED SELECTIVE STREPTOCOCCUS AGAR (K881577) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| SELECTIVE STREPTOCOCCUS AGAR (K881575) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| TINSDALE AGAR BASE (K881555) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| LOWENSTEIN-JENSEN, SELECTIVE (K880125) | Hardy Media | 1988-03-31 |
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 |