FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI
K Number: K991299
·
Decision May 28, 1999
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
20
Applicant Total
70
Review Days
52
Basic Information
- Device Name
- MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI
- K Number
- K991299
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- PRINCETON BIOMEDITECH CORP.
- Date Received
- April 6, 1999
- Decision Date
- May 28, 1999
- Product Code
- JHT
- 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 |
|---|---|---|---|
| JHT | Chromatographic Separation, Cpk Isoenzymes | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
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REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083
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