FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN
K Number: K952360
·
Decision Aug 14, 1995
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
45
Applicant Total
72
Review Days
103
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN
- K Number
- K952360
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5680
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Princeton BioMeditech Corp.
- Date Received
- May 3, 1995
- Decision Date
- August 14, 1995
- Product Code
- DDR
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DDR | Myoglobin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DDR), ordered by most recent decision date.
Access Myoglobin
FDA 510(k)
FDA Class 2
·Immunology
DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET
FDA 510(k)
FDA Class 2
·Immunology
ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
FDA 510(k)
FDA Class 2
·Immunology
ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
FDA 510(k)
FDA Class 2
·Immunology
ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS
FDA 510(k)
FDA Class 2
·Immunology
TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Princeton BioMeditech Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K251538 | Status COVID-19/Flu A&B | Nov 14, 2025 | Substantially Equivalent |
| K182157 | BioSign Flu A+B | Sep 18, 2018 | Substantially Equivalent |
| K130650 | STATUS DS OXY | Feb 26, 2014 | Substantially Equivalent |
| K133474 | BIOSIGN FLU A + B, STATUS FLU A & B | Dec 10, 2013 | Substantially Equivalent |
| K132465 | BIOSIGN FLU A + B, STATUS FLU A & B | Sep 9, 2013 | Substantially Equivalent |
| K083746 | BIOSIGN FLU A+B | Nov 10, 2010 | Substantially Equivalent |
| K100817 | BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST | Jul 1, 2010 | Substantially Equivalent |
| K100341 | SPERMCHECK FERTILITY | May 4, 2010 | Substantially Equivalent |
| K082661 | BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A | Oct 6, 2008 | Substantially Equivalent |
| K073039 | SPERMCHECK VASECTOMY | Jan 24, 2008 | Substantially Equivalent |