Chocolate Agar
FDA 510(k) K851588 · Preferred Micro-Media
510(k) numberK851588
Submission
- Device name
- Chocolate Agar
- Applicant
- Preferred Micro-Media
Toledo, OH, US - Received
- April 16, 1985
- Decision date
- April 30, 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 |
More from Otisville Biopharm, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K851594 | SF BrothJSI · Traditional | 05/14/1985SE |
| K851597 | Triple Sugar Iron AgarJSH · Traditional | 05/13/1985SE |
| K851596 | Sim MediumJSH · Traditional | 05/13/1985SE |
| K851595 | Simmons Citrate AgarJSH · Traditional | 05/13/1985SE |
| K851593 | Selective Streptococcus AgarJSJ · Traditional | 05/13/1985SE |
| K851592 | Sabouraud Dextrose AgarJSJ · Traditional | 05/13/1985SE |
| K851591 | Phenylethyl Alcohol Agar W/5%SHEEP BloodJSJ · Traditional | 05/13/1985SE |
| K851598 | Thioglycollate Without IndicatorJSG · Traditional | 05/10/1985SE |
| K851576 | Biggy Agar Nickersons MediumJSH · Traditional | 05/09/1985SE |
| K851603 | Xylose Lysine Desoxycholate AgarJSI · Traditional | 05/08/1985SE |
Questions and answers
When was Chocolate Agar cleared by the FDA?
Chocolate Agar (K851588) received a 510(k) decision of Substantially Equivalent on April 30, 1985, 14 days after the submission was received.
What is the product code of K851588?
The FDA product code is KZI – Culture Media, Enriched, a Class I (low risk) device regulated under 21 CFR 866.2330.