Product code JSJ
- Device name
- Culture Media, Selective And Non-Differential
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2360
- 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 |
|---|---|---|---|
| K882463 | POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 | Lakewood Biochemical Co., Inc. | 1988-06-22 |
| K881578 | STREPTOSEL | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881574 | W-L DIFFERENTIAL MEDIUM | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881573 | PHYTONE YEAST EXTRACT AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881571 | YM BROTH | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881570 | SABOURAUD MALTOSE AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881565 | INHIBITORY MOLD AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881561 | TERGITOL 7 BROTH | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881549 | MYCOLOGICAL AGAR W/LOW PH | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881547 | MITIS SALIVARIUS AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881544 | LITTMAN AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881530 | BRILLIANT GREEN AGAR W/SULFADIAZINE | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881526 | CHAPMAN STONE MEDIUM | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881524 | DERMATOPHYTE TEST MEDIUM | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K880123 | LOWENSTEIN-JENSEN SLANT | Hardy Media | 1988-03-31 |
| K880124 | LOWENSTEIN-JENSEN, W/NACL | Hardy Media | 1988-03-31 |
| K880141 | BCYE, SELECTIVE (W/MPA) | Hardy Media | 1988-03-30 |
| K880128 | SABOURAUD DEXTROSE AGAR W/CHLORO | Hardy Media | 1988-03-30 |
| K880136 | CETRIMIDE SELECTIVE AGAR | Hardy Media | 1988-03-30 |
| K880137 | BHI WITH C & C SLANT | Hardy Media | 1988-03-30 |
| K880140 | BCYE AGAR | Hardy Media | 1988-03-30 |
| K880945 | CAMPLYOBACTER CULTURE MEDIA PRODUCTS P3873/T3597 | Lakewood Biochemical Co., Inc. | 1988-03-30 |
| K880716 | SLIDE CULTURE PLATE-POTATO FLAKE AGAR | Remel Co. | 1988-03-03 |
| K880717 | SLIDE CULTURE PLATE-POTATO DEXTROSE AGAR | Remel Co. | 1988-03-03 |
| K874176 | BIOTIS (TM) HAEMOPHILUS DUCREYI | Otisville Biopharm, Inc. | 1988-02-05 |
| K874178 | BIOTIS (TM) BCYE SELECTIVE | Otisville Biopharm, Inc. | 1987-12-04 |
| K874345 | TSA W/NEOMYCIN & 5% SHEEP BLOOD - # P3104 & Z3050 | Lakewood Biochemical Co., Inc. | 1987-11-06 |
| K874173 | BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI | Otisville Biopharm, Inc. | 1987-10-28 |
| K874172 | BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR) | Otisville Biopharm, Inc. | 1987-10-28 |
| K873951 | MICRO CULTURE MEDIA P3528, P3137, P3149, P3139 | Lakewood Biochemical Co., Inc. | 1987-10-23 |
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| 18053326000413 | GN Broth | COPAN ITALIA SPA | 2022-12-07 |
| 10814105021238 | ACU-NICKERSON | ACUDERM, INC. | 2020-09-22 |
| 10814105021221 | ACU-SABOURAUD | ACUDERM, INC. | 2020-09-22 |
| 10814105021214 | ACU-DTM | ACUDERM, INC. | 2020-09-22 |
| 10814105021207 | ACU-DTM | ACUDERM, INC. | 2020-09-22 |
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| 00810048900381 | PRAS Fusobacterium Selective Agar (FSA) | ANAEROBE SYSTEMS | 2020-05-01 |
| 00810048900367 | PRAS Bifidobacterium Selective Agar (BIFIDO) | ANAEROBE SYSTEMS | 2020-05-01 |
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| M20215021 | Bullseye Urine | Healthlink | 2016-09-24 |