Streptococcus Selective Agar
FDA 510(k) K844518 · bioMerieux, Inc.
510(k) numberK844518
Submission
- Device name
- Streptococcus Selective Agar
- Applicant
- bioMerieux, Inc.
Addison, IL, US - Received
- November 21, 1984
- Decision date
- January 7, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSJ – Culture Media, Selective And Non-Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
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| K882463 | Potato Dextrose Agar (Pda) - Product #P3421JSJ · Traditional | Lakewood Biochemical Co., Inc. | 06/22/1988SE |
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| K881561 | Tergitol 7 BrothJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881549 | Mycological Agar W/Low PHJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
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| K232967 | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)NGZ · Traditional | 06/12/2024SE |
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| K232201 | VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus…LON · Traditional | 10/23/2023SE |
Questions and answers
When was Streptococcus Selective Agar cleared by the FDA?
Streptococcus Selective Agar (K844518) received a 510(k) decision of Substantially Equivalent on January 7, 1985, 47 days after the submission was received.
What is the product code of K844518?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.