Combigene(Tm) Anti-Dna #Kaddz, KADD1
FDA 510(k) K874873 · Diagnostic Products Corp.
510(k) numberK874873
Submission
- Device name
- Combigene(Tm) Anti-Dna #Kaddz, KADD1
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- November 30, 1987
- Decision date
- February 10, 1988
- 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 Combigene(Tm) Anti-Dna #Kaddz, KADD1 cleared by the FDA?
Combigene(Tm) Anti-Dna #Kaddz, KADD1 (K874873) received a 510(k) decision of Substantially Equivalent on February 10, 1988, 72 days after the submission was received.
What is the product code of K874873?
The FDA product code is DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.