V Agar Selective Deeps
FDA 510(k) K843194 · Remel Co.
510(k) numberK843194
Submission
- Device name
- V Agar Selective Deeps
- Applicant
- Remel Co.
Mchenry, IL, US - Received
- August 14, 1984
- Decision date
- September 14, 1984
- 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
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| K882182 | Salmonella-Shigella (SS) Agar - Product #P3326JSI · Traditional | Lakewood Biochemical Co., Inc. | 06/06/1988SE |
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| K881576 | Selenite BrothJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881575 | Selective Streptococcus AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
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| K031942 | Xpect Giardia Lateral Flow Assay, Model 2450020MHI · Traditional | 11/18/2003SE |
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Questions and answers
When was V Agar Selective Deeps cleared by the FDA?
V Agar Selective Deeps (K843194) received a 510(k) decision of Substantially Equivalent on September 14, 1984, 31 days after the submission was received.
What is the product code of K843194?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.