Product code JTZ
- Device name
- Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.1700
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132491 | MUELLER HINTON AGAR | Edge Biologicals, Inc. | 2014-06-30 |
| K963036 | MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD | Becton Dickinson Microbiology Systems | 1996-10-07 |
| K960420 | MUELLER HINTON AGAR WITH 5% SHEEP BLOOD | Becton Dickinson Microbiology Systems | 1996-04-04 |
| K960313 | MUELLER HINTON AGAR WITH 2% NACI | Remel, L.P. | 1996-03-25 |
| K945911 | CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS | Bioclinical Systems, Inc. | 1995-04-04 |
| K941985 | MUELLER HINTON AGAR W/OXACILLIN | Carr-Scarborough Microbiologicals, Inc. | 1994-08-24 |
| K882351 | MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181 | Lakewood Biochemical Co., Inc. | 1988-06-28 |
| K880105 | MULLER HINTON BROTH | Hardy Media | 1988-03-30 |
| K873268 | MUELLER HINTON MEDIA | Central Media | 1987-11-04 |
| K870649 | MRSA SCREEN AGAR (MUELLER HINTON W/NACL & OXACIL.) | Hardy Media | 1987-04-14 |
| K871097 | CHOCOLATE MUELLER HINTON AGAR | bioMerieux, Inc. | 1987-04-03 |
| K864248 | MUELLER HINTON AGAR - SUPPLEMENTED | Mds Laboratories, Inc. | 1987-03-31 |
| K864247 | MUELLER HINTON AGAR WITH 5% SHEEP BLOOD | Mds Laboratories, Inc. | 1987-03-31 |
| K864246 | MUELLER HINTON AGAR LARGE | Mds Laboratories, Inc. | 1987-03-31 |
| K864245 | MUELLER HINTON AGAR SMALL | Mds Laboratories, Inc. | 1987-03-31 |
| K863821 | MUELLER HINTON AGAR W/4%NACL AND OXACILLIN | Gibco Laboratories Life Technologies, Inc. | 1986-10-09 |
| K861301 | BACTI PLATE (DERMATOLOGY) PRODUCT NO. PS-5000 | Troy Biologicals, Inc. | 1986-04-21 |
| K854521 | BIOGRAM | Giles Scientific, Inc. | 1985-12-23 |
| K854451 | MUELLER HINTON MEDIUM | R. Kent Richards, Inc. | 1985-11-18 |
| K853238 | APL MUELLER HINTON AGAR | Apl Medical Supplies | 1985-08-19 |
| K851225 | URINE DUO | Culture Kits, Inc. | 1985-08-13 |
| K850291 | MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS | Remel Co. | 1985-05-10 |
| K851589 | MUELLER HINTON AGAR & MUELLER HINTON AGAR W/5% SHE | Preferred Micro-Media | 1985-04-30 |
| K851518 | MUELLER HINTON SENSITIVITY PLATE | Culture Kits, Inc. | 1985-04-29 |
| K850715 | MUELLER HINTON AGAR | Rapid City Regional Hospital, Inc. | 1985-03-22 |
| K850843 | MUELLER HINTON CHOCOLATE AGAR | Micro Media Laboratories | 1985-03-20 |
| K850731 | CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP. TESTING | Roseville Medical Laboratoriesu | 1985-03-20 |
| K850553 | MUELLER HINTON AGAR W/CHOCOLATE, MH W/CHOC | Hardy Media | 1985-03-11 |
| K844892 | SLT 220 WASHER FOR MICROITITERPLATES | Slt Labinstruments, Inc. | 1985-02-25 |
| K842854 | MUELLER HINTON BROTH | Anarobe Systems | 1984-08-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00848838090981 | T8006 Sensititre™ Cation Adjusted Mueller-Hinton w/ TES w/ OADC | REMEL, INC. | 2025-01-16 |
| 00848838091360 | Sensititre Middlebrook 7H9 Broth w/OADC | REMEL, INC. | 2024-02-22 |
| 00848838091322 | Sensititre Saline- Tween w/ Glass Beads | REMEL, INC. | 2024-02-22 |
| 00848838020667 | Sensititre Demineralized Water | REMEL, INC. | 2024-02-22 |
| 00848838011177 | Sensititre Demineralized Water | REMEL, INC. | 2023-12-21 |
| 00848838012280 | REMEL | REMEL, INC. | 2022-12-22 |
| 00848838013294 | REMEL | REMEL, INC. | 2022-12-22 |
| 00848838011061 | REMEL | REMEL, INC. | 2022-12-22 |
| 00848838008092 | REMEL | REMEL, INC. | 2022-12-22 |
| 00848838008115 | REMEL | REMEL, INC. | 2022-12-22 |
| 00816576023608 | N/A | HARDY DIAGNOSTICS | 2020-05-27 |
| 30382902219935 | BD BBL™ Mueller Hinton Agar with 5% Sheep Blood | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 30382902219942 | BD BBL™ Mueller Hinton II Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 30382902219522 | BD BBL™ Oxacillin Screen Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 30382902218006 | BD BBL™ Mueller Hinton II Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 30382902212752 | BD BBL™ Mueller Hinton II Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 10382902219948 | BD BBL™ Mueller Hinton II Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 10382902219931 | BD BBL™ Mueller Hinton Agar with 5% Sheep Blood | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 10382902219528 | BD BBL™ Oxacillin Screen Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 10382902218019 | BD BBL™ Mueller Hinton Agar with 5% Sheep Blood | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 10382902218002 | BD BBL™ Mueller Hinton II Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 10382902212758 | BD BBL™ Mueller Hinton II Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 10382902211775 | BD BBL™ Mueller Hinton II Agar | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 10382902211768 | BD BBL™ Mueller Hinton Agar with 5% Sheep Blood | BECTON, DICKINSON AND COMPANY | 2016-12-21 |
| 00848838018855 | NA | REMEL, INC. | 2016-09-24 |
| M20211071 | MUELLER HINTON w 5% SB | Healthlink | 2016-09-24 |
| M20211061 | MUELLER HINTON | Healthlink | 2016-09-24 |
| M20211041 | MUELLER HINTON w 5% SB | Healthlink | 2016-09-24 |
| M20211031 | MUELLER HINTON | Healthlink | 2016-09-24 |
| 00816576020225 | NA | HARDY DIAGNOSTICS | 2016-09-01 |