Titangel High Resolution Control
FDA 510(k) K833639 · Helena Laboratories
510(k) numberK833639
Submission
- Device name
- Titangel High Resolution Control
- Applicant
- Helena Laboratories
Mchenry, IL, US - Received
- October 17, 1983
- Decision date
- January 4, 1984
- 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 Titangel High Resolution Control cleared by the FDA?
Titangel High Resolution Control (K833639) received a 510(k) decision of Substantially Equivalent on January 4, 1984, 79 days after the submission was received.
What is the product code of K833639?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.