FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRITHIDNA ANTI-DNA TEST KIT
K Number: K812314
·
Decision Sep 1, 1981
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
109
Applicant Total
16
Review Days
15
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Basic Information
- Device Name
- CRITHIDNA ANTI-DNA TEST KIT
- K Number
- K812314
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Antibodies, Inc.
- Date Received
- August 17, 1981
- Decision Date
- September 1, 1981
- Product Code
- DHN
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
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|---|---|---|---|
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| K822892 | CORTISOL RIA KIT | Nov 1, 1982 | Substantially Equivalent |
| K812749 | ULTRA-DIG | Oct 19, 1981 | Substantially Equivalent |
| K802877 | AMIKACIN RIA KIT | Dec 19, 1980 | Substantially Equivalent |
| K800743 | TOBRAMYCIN RIA KIT | Apr 16, 1980 | Substantially Equivalent |
| K791217 | TSH RIA KIT | Sep 4, 1979 | Substantially Equivalent |
| K781655 | NEPHELRATE ANTISERUMS 1GA | Nov 8, 1978 | Substantially Equivalent |
| K781654 | NEPHELRATE ANTIPERUMS LGM | Nov 8, 1978 | Substantially Equivalent |
| K781656 | NEPHELRATE ANTISERUMS, IGG | Nov 8, 1978 | Substantially Equivalent |