510(k) K873329
- Device
- HEKTOEN ENTERIC (HE) AGAR PRODUCT #P3330
- Applicant
- LAKEWOOD BIOCHEMICAL CO., INC.
- 510(k) number
- K873329
- Product code
- JSI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-10-02
- Date received
- 1987-08-20
- Regulation
- 866.2360
- Classification name
- Culture Media, Selective And Differential
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Clearance type
- Traditional
- Third party reviewed
- No
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