510(k) K854521
- Device
- BIOGRAM
- Applicant
- GILES SCIENTIFIC, INC.
- 510(k) number
- K854521
- Product code
- JTZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-12-23
- Date received
- 1985-11-12
- Regulation
- 866.1700
- Classification name
- Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID L GIBBS
- Address
- 250 Mercer St. Suite A301 New York NY US 10012 10012
FDA Registration Numbers#
- 1111096
- 1119779
- 1530126
- 8010096
- 2022807
- 3009547954
- 1120041
- 8021914
- 1924669
- 2919016
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JTZ #
| 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 |
Legacy Summary#
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FDA Review#
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