Product Code: DDE
FDA class 1
21 CFR 866.5200
Carbonic Anhydrase C, Antigen, Antiserum, Control
Immunology
This is an immunological reagent kit for detecting carbonic anhydrase C (also called carbonic anhydrase III), an enzyme involved in carbon dioxide transport and acid-base regulation, including antigen, antiserum, and control components for clinical immunoassay testing. It is classified as FDA Class 1, the lowest risk category, subject to general controls only and not requiring premarket notification or approval. The product code is DDE, regulated under 21 CFR 866.5200, within the Immunology specialty.
510(k)s
3
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
8
Basic Information
- Product Code
- DDE
- Device Class
- FDA class 1
- Regulation Number
- 866.5200
- Medical Specialty
- Immunology
- Review Panel
- HE
- Submission Type
- 4
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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K902055 | TENONE(TM) OPIATES CATALOG: VKSO1,4 | Jul 10, 1990 | Substantially Equivalent | DIAGNOSTIC PRODUCTS CORP. |
| K823680 | COAT-A-COUNT MORPHINE KIT & COMPONENTS | Jan 05, 1983 | Substantially Equivalent | DIAGNOSTIC PRODUCTS CORP. |
| K820900 | EMIT URINE METHADONE ASSAY #3E319 | Apr 26, 1982 | Substantially Equivalent | SYVA CO. |