Single (Specified) Analyte Control (Assayed)
FDA 510(k) K894804 · Lifescan, Inc.
510(k) numberK894804
Submission
- Device name
- Single (Specified) Analyte Control (Assayed)
- Applicant
- Lifescan, Inc.
Mountain View, CA, US - Received
- July 28, 1989
- Decision date
- September 28, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Single (Specified) Analyte Control (Assayed) cleared by the FDA?
Single (Specified) Analyte Control (Assayed) (K894804) received a 510(k) decision of Substantially Equivalent on September 28, 1989, 62 days after the submission was received.
What is the product code of K894804?
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.