Positive and Negative HCG Serum Controls
FDA 510(k) K896875 · Armkel, LLC
510(k) numberK896875
Submission
- Device name
- Positive and Negative HCG Serum Controls
- Applicant
- Armkel, LLC
Cranbury, NJ, US - Received
- December 8, 1989
- Decision date
- February 26, 1990
- 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 Positive and Negative HCG Serum Controls cleared by the FDA?
Positive and Negative HCG Serum Controls (K896875) received a 510(k) decision of Substantially Equivalent on February 26, 1990, 80 days after the submission was received.
What is the product code of K896875?
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.