Product code JSF
- Device name
- Culture Media, Single Biochemical Test
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2320
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K880946 | NUTRIENT GELATIN - PRODUCT NUMBER T2860 | Lakewood Biochemical Co., Inc. | 1988-04-01 |
| K880126 | LAURYL TRYPTOSE BROTH | Hardy Media | 1988-03-31 |
| K880120 | MOELLERS DECARBOXYLASE, LYSINE | Hardy Media | 1988-03-31 |
| K880119 | MOELLERS DECARBOXYLASE, ONITHINE | Hardy Media | 1988-03-31 |
| K880139 | ONPG TEST REAGENT | Hardy Media | 1988-03-30 |
| K880135 | NITRATE BROTH | Hardy Media | 1988-03-30 |
| K880129 | BRILLIANT GREEN BILE BROTH | Hardy Media | 1988-03-30 |
| K880118 | MOELLOERS DECARBOXYLASE, ARGININE | Hardy Media | 1988-03-30 |
| K880113 | CYSTINE TRYPTIC MEDIUM W/LACTOSE | Hardy Media | 1988-03-30 |
| K880112 | CYSTINE TRYPTIC MEDIUM W/ MALTOSE | Hardy Media | 1988-03-30 |
| K880111 | CYSTINE TRYPTIC MEDIUM W/SUCROSE | Hardy Media | 1988-03-30 |
| K880110 | CYSTINE TRYPTIC MEDIUM W/DEXTROSE | Hardy Media | 1988-03-30 |
| K880106 | ACETAMIDE AGAR SLANT | Hardy Media | 1988-03-30 |
| K880115 | NUTRIENT GELATIN | Hardy Media | 1988-03-08 |
| K874175 | BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC | Otisville Biopharm, Inc. | 1987-12-04 |
| K874174 | BIOTIS (TM) STARCH HYDROLYSIS WITH BCP | Otisville Biopharm, Inc. | 1987-12-04 |
| K873828 | CULTURE MEDIA T2995/2954/2992/2991/2993/2994/2990 | Lakewood Biochemical Co., Inc. | 1987-10-06 |
| K872691 | IAFP UREA AGAR SLANT | I.A.F. Production, Inc. | 1987-08-11 |
| K870641 | TRYPTONE BROTH, 2% | Hardy Media | 1987-04-14 |
| K864256 | TRYPTONE WATER (1%) | Mds Laboratories, Inc. | 1987-03-31 |
| K864241 | DNASE AGAR | Mds Laboratories, Inc. | 1987-03-31 |
| K862398 | BIOTIS DECARBOXYLASE MEDIA, ORNITHINE | Otisville Biotech, Inc. | 1986-07-03 |
| K862392 | BIOTIS MOTILITY TEST MEDIUM | Otisville Biotech, Inc. | 1986-07-03 |
| K862396 | BIOTIS DECARBOXYLASE MEDIA, ARGININE | Otisville Biotech, Inc. | 1986-07-03 |
| K862397 | BIOTIS DECARBOXYLASE MEDIA, LYSINE | Otisville Biotech, Inc. | 1986-07-03 |
| K850194 | CAFFEIC ACID DISK | Remel Co. | 1985-04-22 |
| K850545 | ACETATE DIFFERENTIAL AGAR | Hardy Media | 1985-03-11 |
| K850550 | SIMMONS CITRATE AGAR | Hardy Media | 1985-03-11 |
| K844544 | CYSTINE TRYPTIC AGAR W/MALTOSE | bioMerieux, Inc. | 1985-01-16 |
| K844543 | CYSTINE TRYPTIC AGAR W/LACTOSE | bioMerieux, Inc. | 1985-01-16 |
Related GUDID Devices#
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|---|---|---|---|
| 00819398025225 | N/A | HARDY DIAGNOSTICS | 2020-06-09 |
| 00819398025201 | N/A | HARDY DIAGNOSTICS | 2020-06-09 |
| 00819398025188 | N/A | HARDY DIAGNOSTICS | 2020-06-09 |
| 00819398025164 | N/A | HARDY DIAGNOSTICS | 2020-06-09 |
| 00819398025126 | N/A | HARDY DIAGNOSTICS | 2020-06-09 |
| 00819398025102 | N/A | HARDY DIAGNOSTICS | 2020-06-09 |
| 00819398025089 | N/A | HARDY DIAGNOSTICS | 2020-06-09 |
| 00819398025065 | N/A | HARDY DIAGNOSTICS | 2020-06-09 |
| 00819398025041 | N/A | HARDY DIAGNOSTICS | 2020-06-09 |
| 00819398025027 | N/A | HARDY DIAGNOSTICS | 2020-06-09 |
| 00819398025003 | N/A | HARDY DIAGNOSTICS | 2020-06-09 |
| 00819398024983 | N/A | HARDY DIAGNOSTICS | 2020-06-09 |
| 00819398024785 | N/A | HARDY DIAGNOSTICS | 2020-06-09 |
| 00819398024587 | N/A | HARDY DIAGNOSTICS | 2020-06-08 |
| 00819398023795 | N/A | HARDY DIAGNOSTICS | 2020-06-05 |
| 00819398023733 | N/A | HARDY DIAGNOSTICS | 2020-06-05 |
| 00819398023276 | N/A | HARDY DIAGNOSTICS | 2020-06-04 |
| 00819398023092 | N/A | HARDY DIAGNOSTICS | 2020-06-04 |
| 00819398023078 | N/A | HARDY DIAGNOSTICS | 2020-06-04 |
| 00819398022675 | N/A | HARDY DIAGNOSTICS | 2020-06-04 |
| 00819398022576 | N/A | HARDY DIAGNOSTICS | 2020-06-03 |
| 00819398022095 | N/A | HARDY DIAGNOSTICS | 2020-06-03 |
| 00819398021876 | N/A | HARDY DIAGNOSTICS | 2020-06-03 |
| 00819398021852 | N/A | HARDY DIAGNOSTICS | 2020-06-03 |
| 00819398021838 | N/A | HARDY DIAGNOSTICS | 2020-06-03 |
| 00819398021432 | N/A | HARDY DIAGNOSTICS | 2020-06-02 |
| 00819398021296 | N/A | HARDY DIAGNOSTICS | 2020-06-01 |
| 00819398021258 | N/A | HARDY DIAGNOSTICS | 2020-06-01 |
| 00819398021159 | N/A | HARDY DIAGNOSTICS | 2020-06-01 |
| 00819398020893 | N/A | HARDY DIAGNOSTICS | 2020-05-24 |