Crithidna Anti-Dna Test Kit
FDA 510(k) K812314 · Antibodies, Inc.
510(k) numberK812314
Submission
- Device name
- Crithidna Anti-Dna Test Kit
- Applicant
- Antibodies, Inc.
Mchenry, IL, US - Received
- August 17, 1981
- Decision date
- September 1, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
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| K791217 | TSH Ria KitJLW · Traditional | 09/04/1979SE |
| K781656 | Nephelrate Antiserums, IggCFN · Traditional | 11/08/1978SE |
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Questions and answers
When was Crithidna Anti-Dna Test Kit cleared by the FDA?
Crithidna Anti-Dna Test Kit (K812314) received a 510(k) decision of Substantially Equivalent on September 1, 1981, 15 days after the submission was received.
What is the product code of K812314?
The FDA product code is DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.