Bcye (Buffered Charcoal Yeast Extract) Agar
FDA 510(k) K854064 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK854064
Submission
- Device name
- Bcye (Buffered Charcoal Yeast Extract) Agar
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Paramus, NJ, US - Received
- October 4, 1985
- Decision date
- October 23, 1985
- 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 |
|---|---|---|---|
| K884208 | Listeria Selective Medium (Oxford Formulation)KZI · Traditional | Oxoid U.S.A., Inc. | 10/25/1988SE |
| 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 |
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| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
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Questions and answers
When was Bcye (Buffered Charcoal Yeast Extract) Agar cleared by the FDA?
Bcye (Buffered Charcoal Yeast Extract) Agar (K854064) received a 510(k) decision of Substantially Equivalent on October 23, 1985, 19 days after the submission was received.
What is the product code of K854064?
The FDA product code is KZI – Culture Media, Enriched, a Class I (low risk) device regulated under 21 CFR 866.2330.