Differential Culture Med. Levine Emb
FDA 510(k) K841843 · Microline Scientific
510(k) numberK841843
Submission
- Device name
- Differential Culture Med. Levine Emb
- Applicant
- Microline Scientific
Mchenry, IL, US - Received
- April 17, 1984
- Decision date
- May 31, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSH – Culture Media, Non-Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2320
- Specialty
- Microbiology
Other 510(k)s with product code JSH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881560 | Urea BrothJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881559 | Urea Agar BaseJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881553 | Russell Double Sugar AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881551 | Phenol Red Broth BaseJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881540 | Flo AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881486 | Dnase Test AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K880121 | Moellers Decarboxylase, BaseJSH · Traditional | Hardy Media | 03/31/1988SE |
| K880117 | Of Medium BaseJSH · Traditional | Hardy Media | 03/30/1988SE |
| K873270 | Actinomycete Differential MediaJSH · Traditional | Central Media | 11/04/1987SE |
| K873263 | Maintenance & Carbohydrate Fermentation MediaJSH · Traditional | Central Media | 10/28/1987SE |
More from Central Media
| 510(k) | Device | Decision |
|---|---|---|
| K841845 | Selective Culture Med. Columbia CnaJSJ · Traditional | 05/31/1984SE |
| K841844 | Differential Culture Medium-Biggy AgarJSI · 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 |
| K841837 | Enriched Culture Med. Fluid THIOGLYC0KZI · Traditional | 05/21/1984SE |
| K841836 | Selective Culture Med. TrichomonasJSD · Traditional | 05/14/1984SE |
Questions and answers
When was Differential Culture Med. Levine Emb cleared by the FDA?
Differential Culture Med. Levine Emb (K841843) received a 510(k) decision of Substantially Equivalent on May 31, 1984, 44 days after the submission was received.
What is the product code of K841843?
The FDA product code is JSH – Culture Media, Non-Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2320.