FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CREATINE KINASE-MB (CK-MB) REAGENT SET
K Number: K915709
·
Decision Jan 27, 1992
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
122
Applicant Total
13
Review Days
59
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Basic Information
- Device Name
- CREATINE KINASE-MB (CK-MB) REAGENT SET
- K Number
- K915709
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tech Intl. Co.
- Date Received
- November 29, 1991
- Decision Date
- January 27, 1992
- Product Code
- CGS
- 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 |
|---|---|---|---|
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CGS), ordered by most recent decision date.
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RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
FDA 510(k)
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CPK REAGENT
FDA 510(k)
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·Clinical Chemistry
DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Tech Intl. Co.
| K Number | Device Name | ||
|---|---|---|---|
| K915704 | AMYLASE (KINETIC) REAGENT SET | Jun 28, 1996 | Substantially Equivalent |
| K915705 | ACID PHOSPHATASE REAGENT SET | Feb 27, 1992 | Substantially Equivalent |
| K915707 | AMMONIA REAGENT SET | Feb 26, 1992 | Substantially Equivalent |
| K914158 | URIC ACID REAGENT SET | Feb 21, 1992 | Substantially Equivalent |
| K915706 | LIPASE REAGENT SET | Feb 18, 1992 | Substantially Equivalent |
| K915710 | AMYLASE (COLORIMETRIC) REAGENT SET | Jan 30, 1992 | Substantially Equivalent |
| K914160 | CHOLESTEROL REGEANT SET | Jan 30, 1992 | Substantially Equivalent |
| K914159 | GLUCOSE REAGENT SET | Jan 27, 1992 | Substantially Equivalent |
| K915708 | INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET | Jan 22, 1992 | Substantially Equivalent |
| K914171 | IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE | Dec 18, 1991 | Substantially Equivalent |