Clearview Positive and Negative Urine HCG Contol Set
FDA 510(k) K934923 · Unipath , Ltd.
510(k) numberK934923
Submission
- Device name
- Clearview Positive and Negative Urine HCG Contol Set
- Applicant
- Unipath , Ltd.
Bedford Mk41 Oqg, GB - Received
- October 13, 1993
- Decision date
- December 29, 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 Clearview Positive and Negative Urine HCG Contol Set cleared by the FDA?
Clearview Positive and Negative Urine HCG Contol Set (K934923) received a 510(k) decision of Substantially Equivalent on December 29, 1993, 77 days after the submission was received.
What is the product code of K934923?
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.