Architect TSH Mastercheck, List No, 6C52-05
FDA 510(k) K984072 · Bio-Rad
510(k) numberK984072
Submission
- Device name
- Architect TSH Mastercheck, List No, 6C52-05
- Applicant
- Bio-Rad
Irvine, CA, US - Received
- November 16, 1998
- Decision date
- November 24, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Architect TSH Mastercheck, List No, 6C52-05 cleared by the FDA?
Architect TSH Mastercheck, List No, 6C52-05 (K984072) received a 510(k) decision of Substantially Equivalent on November 24, 1998, 8 days after the submission was received.
What is the product code of K984072?
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.