Enriched Culture Med. Fluid THIOGLYC0
FDA 510(k) K841837 · Microline Scientific
510(k) numberK841837
Submission
- Device name
- Enriched Culture Med. Fluid THIOGLYC0
- Applicant
- Microline Scientific
Mchenry, IL, US - Received
- April 17, 1984
- Decision date
- May 21, 1984
- 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 |
|---|---|---|
| K841845 | Selective Culture Med. Columbia CnaJSJ · Traditional | 05/31/1984SE |
| K841844 | Differential Culture Medium-Biggy AgarJSI · Traditional | 05/31/1984SE |
| K841843 | Differential Culture Med. Levine EmbJSH · Traditional | 05/31/1984SE |
| K841842 | Differential Culture Med. Macconkey AgarJSI · Traditional | 05/31/1984SE |
| K841586 | Chocolate AgarKZI · Traditional | 05/31/1984SE |
| K841841 | Differential Culture Med. Mannitol SaltJSI · Traditional | 05/25/1984SE |
| K841840 | Selective Culture Med. Phenylethyl AlcoJSJ · Traditional | 05/25/1984SE |
| K841839 | Selective Culture Med. Selective StrepJSJ · Traditional | 05/25/1984SE |
| K841838 | Enriched Culture Med. Tryptic Soy AgarKZI · Traditional | 05/21/1984SE |
| K841836 | Selective Culture Med. TrichomonasJSD · Traditional | 05/14/1984SE |
Questions and answers
When was Enriched Culture Med. Fluid THIOGLYC0 cleared by the FDA?
Enriched Culture Med. Fluid THIOGLYC0 (K841837) received a 510(k) decision of Substantially Equivalent on May 21, 1984, 34 days after the submission was received.
What is the product code of K841837?
The FDA product code is KZI – Culture Media, Enriched, a Class I (low risk) device regulated under 21 CFR 866.2330.