MUELLER HINTON W/50% SHEEP BLOOD
FDA 510(k) clearance K830059 · decided 1983-02-09
Clearance details
- K-number
- K830059
- Device name
- MUELLER HINTON W/50% SHEEP BLOOD
- 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
- JTC
- Device class
- 1
- Regulation number
- 866.2500
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch bioMerieux
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FILTERMATE UNIVERSAL HARVESTER (K924907) | Packard Instrument Co., Inc. | 1992-12-01 |
| MICROMATE 196 MODEL A961960 (K901808) | Packard Instrument Co., Inc. | 1990-06-20 |
| IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM (K894645) | Dynatech Laboratories, Inc. | 1989-10-17 |
| MULTI-PROBE HEAD PLUS (K892369) | Hamilton Co. | 1989-06-02 |
| GENETIC SYSTEMS MICROPLATE WASHER (K891768) | Genetic Systems Corp. | 1989-05-01 |
| GENETIC SYSTEMS MICROPLATE STRIP WASHER (K891766) | Genetic Systems Corp. | 1989-05-01 |
| GENETIC SYSTEMS PIPETTOR/DILUTOR (K891765) | Genetic Systems Corp. | 1989-05-01 |
| WASHER 500 MICROELISA SYSTEM (K884695) | Organon Teknika Corp. | 1988-12-13 |
| BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403 (K884125) | Bio-Tek Instruments, Inc. | 1988-12-02 |
| DYNATECH MR 250 MANUAL MICROELISA READER (K874598) | Dynatech Laboratories, Inc. | 1987-11-20 |
| MICROPLATE AUTO-WASHER (MOTORIZED STAGE) (K873542) | Genetic Systems Corp. | 1987-09-23 |
| MICROLAB AT (K871945) | Hamilton Co. | 1987-05-29 |
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 |