510(k) K851578
- Device
- BILE ESCULIN AGAR
- Applicant
- PREFERRED MICRO-MEDIA
- 510(k) number
- K851578
- Product code
- JSI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-05-08
- Date received
- 1985-04-16
- Regulation
- 866.2360
- Classification name
- Culture Media, Selective And Differential
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT SCOTT
- Address
- 5223 Telegraph Rd. Toledo OH US 43612 43612
FDA Registration Numbers#
- 3013394941
- 1119779
- 8010096
- 9680687
- 1210083
- 3017717188
- 2951280
- 3017871324
- 3015715780
- 2249224
- 3005182157
- 1924669
- 3033815621
- 2016672
- 9615755
- 1111096
- 2022807
- 3009307598
- 3012162776
- 3005182159
- 9610649
- 3013823481
- 3035708936
- 9610102
- 8023060
- 9611882
- 2916932
- 8030124
- 3038136284
- 3009547954
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JSI #
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases