Product Code: DID
FDA class 2
21 CFR 862.3900
Bacillus Subtilis Microbiology Assay, Tobramycin
Clinical Toxicology
The Bacillus Subtilis Microbiology Assay for Tobramycin is a microbiological test system used to measure tobramycin, an aminoglycoside antibiotic, concentrations in patient specimens using Bacillus subtilis as an indicator organism for antimicrobial activity. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3900 within the Clinical Toxicology specialty. The device qualifies for third-party 510(k) review.
510(k)s
5
FEI Numbers
0
Registration Numbers
0
Unique Applicants
5
Years Active
4
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Basic Information
- Product Code
- DID
- Device Class
- FDA class 2
- Regulation Number
- 862.3900
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- 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 |
|---|---|---|---|---|
| K820773 | EMIT-ST URINE COCAINE METABOLITE ASSAY | Apr 08, 1982 | Substantially Equivalent | Syva Co. |
| K802038 | PHENYTOIN REAGENT TEST KIT | Oct 23, 1980 | Substantially Equivalent | Beckman Instruments, Inc. |
| K780950 | BIO-MONITOR TOBRAMYCIN | Aug 14, 1978 | Substantially Equivalent | Monitor Science Corp. |
| K780182 | TOBRAMYCIN 125I RIA KIT | Feb 13, 1978 | Substantially Equivalent | New England Nuclear |
| K780048 | AMINOGLYCOSIDE TEST SYSTEM | Jan 20, 1978 | Substantially Equivalent | Nichols Institute Diagnostics |