Immulite TSH Third Generation Control
FDA 510(k) K930007 · Diagnostic Products Corp.
510(k) numberK930007
Submission
- Device name
- Immulite TSH Third Generation Control
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- January 4, 1993
- Decision date
- August 16, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Immulite TSH Third Generation Control cleared by the FDA?
Immulite TSH Third Generation Control (K930007) received a 510(k) decision of Substantially Equivalent on August 16, 1993, 224 days after the submission was received.
What is the product code of K930007?
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.