FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALT-30, 60 AND 100
K Number: K861366
·
Decision Jun 25, 1986
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
126
Applicant Total
8
Review Days
75
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Basic Information
- Device Name
- ALT-30, 60 AND 100
- K Number
- K861366
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1030
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Dimension Diagnostics
- Date Received
- April 11, 1986
- Decision Date
- June 25, 1986
- Product Code
- CKA
- 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 |
|---|---|---|---|
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | FDA class 1 | Clinical Chemistry |
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Other Clearances by Dimension Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K863223 | DIMENSION-WBG | Mar 10, 1987 | Substantially Equivalent |
| K854967 | CRITIC - SF, ASSAYED | Jan 7, 1986 | Substantially Equivalent |
| K853943 | CRITIC C LEVEL I & II | Dec 23, 1985 | Substantially Equivalent |
| K852295 | UROL-GUANT | Jul 22, 1985 | Substantially Equivalent |
| K844848 | IMA-TROL IMMUNOASSAY CONTROL | Mar 1, 1985 | Substantially Equivalent |
| K844760 | UROL-QUAL | Jan 8, 1985 | Substantially Equivalent |
| K844709 | CRITIC-ARS | Jan 8, 1985 | Substantially Equivalent |