FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG
K Number: K945514
·
Decision Feb 10, 1995
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
225
Applicant Total
72
Review Days
93
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Basic Information
- Device Name
- LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG
- K Number
- K945514
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Princeton BioMeditech Corp.
- Date Received
- November 9, 1994
- Decision Date
- February 10, 1995
- Product Code
- LCX
- 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 |
|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | FDA class 2 | Clinical Chemistry |
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