FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRA ZYME PLUS CK-1 #64978, 65027 & 28
K Number: K812593
·
Decision Oct 2, 1981
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
122
Applicant Total
116
Review Days
21
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Basic Information
- Device Name
- ULTRA ZYME PLUS CK-1 #64978, 65027 & 28
- K Number
- K812593
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Harleco
- Date Received
- September 11, 1981
- Decision Date
- October 2, 1981
- 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 Harleco
| K Number | Device Name | ||
|---|---|---|---|
| K820233 | ULTRAZYME PLUS GAMMA GT(65055-65056) | Feb 12, 1982 | Substantially Equivalent |
| K813427 | ULTRACHEM GLUC-DH | Dec 31, 1981 | Substantially Equivalent |
| K813042 | ULTRACHEM GLUC-DH SET, ITEM #65048 | Nov 10, 1981 | Substantially Equivalent |
| K813039 | ULTRACHEM E-CHOL, ITEM #65025 | Nov 10, 1981 | Substantially Equivalent |
| K813043 | ULTRACHEM CREA ITEM #64972 | Nov 10, 1981 | Substantially Equivalent |
| K813040 | ULTRACHEM CA, ITEM #64975 | Nov 10, 1981 | Substantially Equivalent |
| K813044 | ULTRACHEM ALB, ITEM #64970 | Nov 10, 1981 | Substantially Equivalent |
| K813041 | ULTRAZYME-GT, ITEM #64959 & 65032 | Nov 10, 1981 | Substantially Equivalent |
| K813038 | ULTRACHEM TP, ITEM #64974 | Nov 10, 1981 | Substantially Equivalent |
| K812594 | ULTRA ZYME PLUS AMYL #64982 & 65031 | Oct 2, 1981 | Substantially Equivalent |