Product Code: LKA
FDA class 2
21 CFR 866.1700
Culture Media, Antimicrobial Susceptibility Test
Microbiology
Culture Media, Antimicrobial Susceptibility Test is a laboratory reagent consisting of growth media formulated to support bacterial growth while allowing determination of the susceptibility or resistance of microorganisms to specific antimicrobial agents. This is an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LKA, regulated under 21 CFR 866.1700, within the Microbiology medical specialty. This device is eligible for third-party 510(k) review.
510(k)s
5
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
4
Basic Information
- Product Code
- LKA
- Device Class
- FDA class 2
- Regulation Number
- 866.1700
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K872688 | IAFP MUELLER HINTON AGAR W/5% SHEEP BLOOD | Aug 11, 1987 | Substantially Equivalent | I.A.F. Production, Inc. |
| K872687 | IAFP MUELLER HINTON AGAR W/HEMO. W/CVA ENRICHMENT | Aug 11, 1987 | Substantially Equivalent | I.A.F. Production, Inc. |
| K872686 | IAFP MUELLER HINTON AGAR | Aug 11, 1987 | Substantially Equivalent | I.A.F. Production, Inc. |
| K833218 | YEAST BEEF AGAR-ANTIBIOTIC MED.4 | Oct 27, 1983 | Substantially Equivalent | Acumedia Manufacturers, Inc. |
| K833207 | AK AGAR 2 | Oct 27, 1983 | Substantially Equivalent | Acumedia Manufacturers, Inc. |