Product code JSI
- Device name
- Culture Media, Selective And 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 |
|---|---|---|---|
| K070691 | BBL CHROMAGAR 0157 | Becton, Dickinson & CO | 2007-11-20 |
| K974428 | DIPSTREAK | Novamed , Ltd. | 1998-07-30 |
| K891593 | LISTERIA SELECTIVE ENRICHMENT MEDIUM | Oxoid U.S.A., Inc. | 1989-06-09 |
| K890199 | DENTOCULT SM-STRIP MUTANS | Orion Corp. | 1989-03-02 |
| K882182 | SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326 | Lakewood Biochemical Co., Inc. | 1988-06-06 |
| K881577 | MODIFIED SELECTIVE STREPTOCOCCUS AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881576 | SELENITE BROTH | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881575 | SELECTIVE STREPTOCOCCUS AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881572 | XL AGAR BASE | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881556 | TRICHOMONAS BROTH | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881555 | TINSDALE AGAR BASE | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K880125 | LOWENSTEIN-JENSEN, SELECTIVE | Hardy Media | 1988-03-31 |
| K880132 | DERMATOPHYTE TEST MEDIUM | Hardy Media | 1988-03-30 |
| K880130 | ATS MEDIA | Hardy Media | 1988-03-30 |
| K880108 | CORN MEAL W/POLYSORBATE 80 | Hardy Media | 1988-03-30 |
| K873258 | STREPTOCOCCAL SELECTIVE DIFFEREN. & ENRICHED MEDIA | Central Media | 1987-11-06 |
| K873259 | SPECIALTY MEDIA | Central Media | 1987-11-06 |
| K873260 | CORYNEBACTERIA ISOLATION MEDIA | Central Media | 1987-11-06 |
| K874344 | QUAD PLATE (4 DIFFERENT MEDIA) | Lakewood Biochemical Co., Inc. | 1987-11-06 |
| K873269 | MYCOLOGICAL MEDIA | Central Media | 1987-11-04 |
| K873265 | MEDIA FOR ANAEROBIC/MICROAERPHILIC ISOLATION | Central Media | 1987-10-28 |
| K873264 | MEDIA FOR DETECTION & VERIFICATION OF COLIFORMS | Central Media | 1987-10-28 |
| K873262 | DIFFERENTIAL MEDIA | Central Media | 1987-10-28 |
| K873261 | ENTERIC ISOLATION MEDIA | Central Media | 1987-10-28 |
| K873481 | HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016 | Lakewood Biochemical Co., Inc. | 1987-10-08 |
| K873329 | HEKTOEN ENTERIC (HE) AGAR PRODUCT #P3330 | Lakewood Biochemical Co., Inc. | 1987-10-02 |
| K873227 | MANNITOL SALT AGAR (MSA) PRODUCT #P1706 | Lakewood Biochemical Co., Inc. | 1987-09-23 |
| K873223 | MACCONKEY AGAR - PRODUCT #P1606 | Lakewood Biochemical Co., Inc. | 1987-09-23 |
| K873225 | EOSIN METHYLENE BLUE AGAR (EMB) - PRODUCT #P1309 | Lakewood Biochemical Co., Inc. | 1987-09-23 |
| K873226 | XYLOSE LYSINE DEOXYCHOLATE AGAR - PRODUCT #P3601 | Lakewood Biochemical Co., Inc. | 1987-09-23 |
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| B6451R180 | EDGE BIOLOGICALS INC | EDGE BIOLOGICALS, INC. | 2025-04-17 |
| B645T0236 | EDGE BIOLOGICALS INC | EDGE BIOLOGICALS, INC. | 2025-04-17 |
| B6454P376 | EDGE BIOLOGICALS INC | EDGE BIOLOGICALS, INC. | 2025-04-17 |
| B6454P375 | EDGE BIOLOGICALS INC | EDGE BIOLOGICALS, INC. | 2025-04-17 |
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| B6451R111 | EDGE BIOLOGICALS INC | EDGE BIOLOGICALS, INC. | 2025-04-17 |
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| B08815930 | InTray DM-FungID | BIO-MED DIAGNOSTICS, INC. | 2020-02-10 |
| B08811130 | InTray® COLOREX Yeast | BIO-MED DIAGNOSTICS, INC. | 2018-09-13 |
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