FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET
K Number: K934923
·
Decision Dec 29, 1993
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
492
Applicant Total
73
Review Days
77
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Basic Information
- Device Name
- CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET
- K Number
- K934923
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Unipath , Ltd.
- Date Received
- October 13, 1993
- Decision Date
- December 29, 1993
- Product Code
- JJX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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| K033658 | E.P.T. PREGNANCY TEST | Jan 16, 2004 | Substantially Equivalent |
| K032939 | EPT CERTAINTY PREGNANCY TEST | Oct 20, 2003 | Substantially Equivalent |