FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ULTRACHEM TRI-ES
K Number: K821875
·
Decision Jul 13, 1982
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
150
Applicant Total
23
Review Days
18
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Basic Information
- Device Name
- ULTRACHEM TRI-ES
- K Number
- K821875
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1705
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Harleco Diagnostics
- Date Received
- June 25, 1982
- Decision Date
- July 13, 1982
- Product Code
- CDT
- 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 |
|---|---|---|---|
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | FDA class 1 | Clinical Chemistry |
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Other Clearances by Harleco Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K823147 | URIC ACID STANDARD, 8MG/DL #65078 | Nov 22, 1982 | Substantially Equivalent |
| K822852 | TRIGLYCERIDE CALIBRATOR | Oct 27, 1982 | Substantially Equivalent |
| K822323 | ULTRACHEM BUN-UV, 65080 & 65081 | Sep 2, 1982 | Substantially Equivalent |
| K821878 | ULTRAZYME PLUS LDH | Jul 14, 1982 | Substantially Equivalent |
| K821873 | ULTRACHEM T-BILI | Jul 14, 1982 | Substantially Equivalent |
| K821880 | ULTRA CHEM ALB | Jul 14, 1982 | Substantially Equivalent |
| K821882 | ULTRAZYME PLUS GPT | Jul 14, 1982 | Substantially Equivalent |
| K821877 | ULTRAZYME PLUS HBD | Jul 14, 1982 | Substantially Equivalent |
| K821883 | ULTRAZYME PLUS CK-I | Jul 14, 1982 | Substantially Equivalent |
| K821871 | ULTRAZYME PLUS 2GT | Jul 14, 1982 | Substantially Equivalent |