FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODULE: NOVA NUCLEUS TMG MODULE FLUID PACK
K Number: K912321
·
Decision Jun 17, 1991
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
89
Applicant Total
89
Review Days
24
Basic Information
- Device Name
- MODULE: NOVA NUCLEUS TMG MODULE FLUID PACK
- K Number
- K912321
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1495
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- NOVA BIOMEDICAL CORP.
- Date Received
- May 24, 1991
- Decision Date
- June 17, 1991
- Product Code
- JGJ
- 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 |
|---|---|---|---|
| JGJ | Photometric Method, Magnesium | FDA class 1 | Clinical Chemistry |
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| K061830 | STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ | Nov 1, 2006 | Substantially Equivalent |
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