FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
K Number: K041946
·
Decision Aug 16, 2004
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
374
Applicant Total
85
Review Days
28
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Basic Information
- Device Name
- ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
- K Number
- K041946
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ACON Laboratories, Inc.
- Date Received
- July 19, 2004
- Decision Date
- August 16, 2004
- 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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