Solution, Antimicrobial
Solution, Antimicrobial is a liquid preparation containing antimicrobial agents used in laboratory microbiology settings, such as for selective inhibition of unwanted microbial growth in culture media or as a supplement in diagnostic test systems. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LOP, regulated under 21 CFR 866.1640, within the Microbiology medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- LOP
- Device Class
- FDA class 2
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K902004 | TROBICIN SUSCEPTIBILITY POWDER | May 15, 1990 | Substantially Equivalent | The Upjohn Co. |
| K900455 | ZEFAZONE SUSCEPTIBILITY POWDER | Feb 09, 1990 | Substantially Equivalent | The Upjohn Co. |
| K810471 | STOCK ANTIMICROBIC SOLUTIONS | Apr 01, 1981 | Substantially Equivalent | Cathra International, Inc. |