FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
ABSOLUTE(TM)-HCG URINE PREGNANCY TEST
K Number: K893953
·
Decision Aug 15, 1989
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
71
Applicant Total
1
Review Days
75
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Basic Information
- Device Name
- ABSOLUTE(TM)-HCG URINE PREGNANCY TEST
- K Number
- K893953
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Totem Diagnostics, Inc.
- Date Received
- June 1, 1989
- Decision Date
- August 15, 1989
- Product Code
- DHA
- 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 |
|---|---|---|---|
| DHA | System, Test, Human Chorionic Gonadotropin | FDA class 2 | Clinical Chemistry |
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