Listeria Selective Enrichment Medium
FDA 510(k) K891593 · Oxoid U.S.A., Inc.
510(k) numberK891593
Submission
- Device name
- Listeria Selective Enrichment Medium
- Applicant
- Oxoid U.S.A., Inc.
Columbia, MD, US - Received
- March 20, 1989
- Decision date
- June 9, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSI – Culture Media, Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
Other 510(k)s with product code JSI
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|---|---|---|---|
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| K974428 | DipstreakJSI · Traditional | Novamed , Ltd. | 07/30/1998SE |
| K890199 | Dentocult Sm-Strip MutansJSI · Traditional | Orion Corp. | 03/02/1989SE |
| K882182 | Salmonella-Shigella (SS) Agar - Product #P3326JSI · Traditional | Lakewood Biochemical Co., Inc. | 06/06/1988SE |
| K881577 | Modified Selective Streptococcus AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881576 | Selenite BrothJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881575 | Selective Streptococcus AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881572 | XL Agar BaseJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881556 | Trichomonas BrothJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881555 | Tinsdale Agar BaseJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
More from Acumedia Manufacturers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K884026 | Escherichia Coli 0157 Latex Agglutination Test KitGNA · Traditional | 02/03/1989SE |
| K884208 | Listeria Selective Medium (Oxford Formulation)KZI · Traditional | 10/25/1988SE |
| K874303 | Staphylase TestLHT · Traditional | 11/06/1987SE |
| K872956 | Sorbitol Macconkey Agar No. 3 CM 813JSI · Traditional | 08/10/1987SE |
| K872135 | Mcbride Medium CM 819JSJ · Traditional | 06/15/1987SE |
| K870945 | Rabbit Plasma Fibrinogen Supplement SR 122JTL · Traditional | 06/10/1987SE |
| K862946 | Oxoid Signal Blood Culture SystemJSG · Traditional | 11/05/1986SE |
| K855236 | Diagnostic Reagent Tst-RplaGTN · Traditional | 11/04/1986SE |
| K855235 | Diagnostic Reagent Pet-RplaJSP · Traditional | 11/04/1986SE |
| K855234 | Diagnostic Reagent Vet-RplaGNA · Traditional | 11/04/1986SE |
Questions and answers
When was Listeria Selective Enrichment Medium cleared by the FDA?
Listeria Selective Enrichment Medium (K891593) received a 510(k) decision of Substantially Equivalent on June 9, 1989, 81 days after the submission was received.
What is the product code of K891593?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.