FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STATUS HCG SERUM/URINE
K Number: K020439
·
Decision May 23, 2002
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
374
Applicant Total
72
Review Days
101
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Basic Information
- Device Name
- STATUS HCG SERUM/URINE
- K Number
- K020439
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Princeton BioMeditech Corp.
- Date Received
- February 11, 2002
- Decision Date
- May 23, 2002
- Product Code
- JHI
- 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | FDA class 2 | Clinical Chemistry |
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