FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CREATINE KINASE-MB REAGENT SET
K Number: K971566
·
Decision Jul 14, 1997
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
122
Applicant Total
7
Review Days
76
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Basic Information
- Device Name
- CREATINE KINASE-MB REAGENT SET
- K Number
- K971566
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Horizon Diagnostics, Inc.
- Date Received
- April 29, 1997
- Decision Date
- July 14, 1997
- 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 |
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Other Clearances by Horizon Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933722 | HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT | Jun 13, 1996 | Substantially Equivalent |
| K935712 | IRON/TIBC REAGENT | Sep 20, 1995 | Substantially Equivalent |
| K930678 | AMYLASE | Apr 6, 1994 | Substantially Equivalent |
| K934533 | BUN-300/BUN-500 UREA NITROGEN REAGENT | Nov 26, 1993 | Substantially Equivalent |
| K930679 | DIRECT BILIRUBIN | Jun 29, 1993 | Substantially Equivalent |
| K930074 | IN-VITRO DIAGNOSTIC REAGENT SET | May 11, 1993 | Substantially Equivalent |