Response Liquid Ligand Assay Serum
FDA 510(k) K821242 · Beckman Instruments, Inc.
510(k) numberK821242
Submission
- Device name
- Response Liquid Ligand Assay Serum
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- April 29, 1982
- Decision date
- May 21, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Response Liquid Ligand Assay Serum cleared by the FDA?
Response Liquid Ligand Assay Serum (K821242) received a 510(k) decision of Substantially Equivalent on May 21, 1982, 22 days after the submission was received.
What is the product code of K821242?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.