Quantitate Uric Acid Verifier Set
FDA 510(k) K944453 · Beckman Instruments, Inc.
510(k) numberK944453
Submission
- Device name
- Quantitate Uric Acid Verifier Set
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- September 12, 1994
- Decision date
- November 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Quantitate Uric Acid Verifier Set cleared by the FDA?
Quantitate Uric Acid Verifier Set (K944453) received a 510(k) decision of Substantially Equivalent on November 22, 1994, 71 days after the submission was received.
What is the product code of K944453?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.