Crithidia Luciliae Native Dna-Ifa Test
FDA 510(k) K810301 · Immuno Concepts, Inc.
510(k) numberK810301
Submission
- Device name
- Crithidia Luciliae Native Dna-Ifa Test
- Applicant
- Immuno Concepts, Inc.
Mchenry, IL, US - Received
- February 4, 1981
- Decision date
- February 25, 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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Questions and answers
When was Crithidia Luciliae Native Dna-Ifa Test cleared by the FDA?
Crithidia Luciliae Native Dna-Ifa Test (K810301) received a 510(k) decision of Substantially Equivalent on February 25, 1981, 21 days after the submission was received.
What is the product code of K810301?
The FDA product code is DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.