FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CK-MB
K Number: K771497
·
Decision Aug 22, 1977
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
20
Applicant Total
340
Review Days
17
Basic Information
- Device Name
- CK-MB
- K Number
- K771497
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- BOEHRINGER MANNHEIM CORP.
- Date Received
- August 5, 1977
- Decision Date
- August 22, 1977
- 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
Other 510(k) clearances with the same product code (JHT), ordered by most recent decision date.
SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST
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MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI
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CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305
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COULTER CK-MB ISOENZYME REAGENT
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DSL CK-MB (DSL #3200)
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MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB
FDA 510(k)
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·Clinical Chemistry
Other Clearances by BOEHRINGER MANNHEIM CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K984326 | ELECYS IGE ASSAY | Feb 8, 1999 | Substantially Equivalent |
| K983047 | ACCU-CHEK HQ SYSTEM | Feb 5, 1999 | Substantially Equivalent |
| K984419 | ELECSYS IGE CALCHECK | Feb 2, 1999 | Substantially Equivalent |
| K984425 | MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR | Jan 20, 1999 | Substantially Equivalent |
| K984372 | ELECSYS CALCHECK TROPONIN T | Dec 14, 1998 | Substantially Equivalent |
| K984105 | ELECSYS TROPONIN T STAT TEST | Dec 8, 1998 | Substantially Equivalent |
| K983503 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 | Dec 1, 1998 | Substantially Equivalent |
| K983469 | PRECISET SERUM PROTEINS CALIBRATOR | Nov 25, 1998 | Substantially Equivalent |
| K983185 | BOEHRINGER MANNHEIM TINA-QUANT IGE TEST | Nov 12, 1998 | Substantially Equivalent |
| K982949 | ELECSYS PSA, MODEL 2010 | Oct 27, 1998 | Substantially Equivalent |