Architect Total P-Hcg Mastercheck, List No. 6C21-05
FDA 510(k) K984073 · Bio-Rad
510(k) numberK984073
Submission
- Device name
- Architect Total P-Hcg Mastercheck, List No. 6C21-05
- Applicant
- Bio-Rad
Irvine, CA, US - Received
- November 16, 1998
- Decision date
- November 25, 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 Total P-Hcg Mastercheck, List No. 6C21-05 cleared by the FDA?
Architect Total P-Hcg Mastercheck, List No. 6C21-05 (K984073) received a 510(k) decision of Substantially Equivalent on November 25, 1998, 9 days after the submission was received.
What is the product code of K984073?
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.