FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IN-HOME EARLY PREGNANCY TEST KIT
K Number: K802334
·
Decision Oct 10, 1980
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
95
Applicant Total
2
Review Days
17
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Basic Information
- Device Name
- IN-HOME EARLY PREGNANCY TEST KIT
- K Number
- K802334
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Health Diagnostics Corp.
- Date Received
- September 23, 1980
- Decision Date
- October 10, 1980
- Product Code
- JHJ
- 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 |
|---|---|---|---|
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | FDA class 2 | Clinical Chemistry |
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Other Clearances by Health Diagnostics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K801449 | BLOOD GAS CONTROL PROD. NO. BG-1, BG-2 | Jul 21, 1980 | Substantially Equivalent |