Il Test Igg Iga & Igm Kits
FDA 510(k) K833841 · Instrumentation Laboratory CO
510(k) numberK833841
Submission
- Device name
- Il Test Igg Iga & Igm Kits
- Applicant
- Instrumentation Laboratory CO
Mchenry, IL, US - Received
- November 7, 1983
- Decision date
- January 4, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CZK – Iga, Rhodamine, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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Questions and answers
When was Il Test Igg Iga & Igm Kits cleared by the FDA?
Il Test Igg Iga & Igm Kits (K833841) received a 510(k) decision of Substantially Equivalent on January 4, 1984, 58 days after the submission was received.
What is the product code of K833841?
The FDA product code is CZK – Iga, Rhodamine, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.