Listeria Selective Medium (Oxford Formulation)
FDA 510(k) K884208 · Oxoid U.S.A., Inc.
510(k) numberK884208
Submission
- Device name
- Listeria Selective Medium (Oxford Formulation)
- Applicant
- Oxoid U.S.A., Inc.
Columbia, MD, US - Received
- October 6, 1988
- Decision date
- October 25, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KZI – Culture Media, Enriched
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2330
- Specialty
- Microbiology
Other 510(k)s with product code KZI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881995 | Diamond's Medium ModifiedKZI · Traditional | Remel Co. | 06/02/1988SE |
| K880134 | Middlebrook 7H11 AgarKZI · Traditional | Hardy Media | 03/31/1988SE |
| K880131 | Lowenstein-Jensen, GruftKZI · Traditional | Hardy Media | 03/31/1988SE |
| K880122 | Middlebrook 7H9 BrothKZI · Traditional | Hardy Media | 03/31/1988SE |
| K880138 | Wallenstein Medium SlantKZI · Traditional | Hardy Media | 03/30/1988SE |
| K880109 | Cystine Tryptic Medium BaseKZI · Traditional | Hardy Media | 03/30/1988SE |
| K880127 | Potato Dextrose AgarKZI · Traditional | Hardy Media | 03/07/1988SE |
| K874179 | Biotis (TM) Sabhi (Double Pour)KZI · Traditional | Otisville Biopharm, Inc. | 01/28/1988SE |
| K874177 | Biotis (TM) BcyeKZI · Traditional | Otisville Biopharm, Inc. | 12/04/1987SE |
| K873267 | ECG Based MediaKZI · Traditional | Central Media | 11/04/1987SE |
More from Central Media
| 510(k) | Device | Decision |
|---|---|---|
| K891593 | Listeria Selective Enrichment MediumJSI · Traditional | 06/09/1989SE |
| K884026 | Escherichia Coli 0157 Latex Agglutination Test KitGNA · Traditional | 02/03/1989SE |
| 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 Medium (Oxford Formulation) cleared by the FDA?
Listeria Selective Medium (Oxford Formulation) (K884208) received a 510(k) decision of Substantially Equivalent on October 25, 1988, 19 days after the submission was received.
What is the product code of K884208?
The FDA product code is KZI – Culture Media, Enriched, a Class I (low risk) device regulated under 21 CFR 866.2330.