EIA-F8 Enzymeimmunoassay Kit for Quant.
FDA 510(k) K821963 · Intl. Immunoassay Laboratories, Inc.
510(k) numberK821963
Submission
- Device name
- EIA-F8 Enzymeimmunoassay Kit for Quant.
- Applicant
- Intl. Immunoassay Laboratories, Inc.
Mchenry, IL, US - Received
- July 1, 1982
- Decision date
- July 27, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
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Questions and answers
When was EIA-F8 Enzymeimmunoassay Kit for Quant. cleared by the FDA?
EIA-F8 Enzymeimmunoassay Kit for Quant. (K821963) received a 510(k) decision of Substantially Equivalent on July 27, 1982, 26 days after the submission was received.
What is the product code of K821963?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.