Fetal-Tek Control (Immature/Borderline)
FDA 510(k) K820772 · Helena Laboratories
510(k) numberK820772
Submission
- Device name
- Fetal-Tek Control (Immature/Borderline)
- Applicant
- Helena Laboratories
Walker, MI, US - Received
- March 23, 1982
- Decision date
- May 12, 1982
- 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 Fetal-Tek Control (Immature/Borderline) cleared by the FDA?
Fetal-Tek Control (Immature/Borderline) (K820772) received a 510(k) decision of Substantially Equivalent on May 12, 1982, 50 days after the submission was received.
What is the product code of K820772?
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.