FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMA-TROL IMMUNOASSAY CONTROL
K Number: K844848
·
Decision Mar 1, 1985
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
8
Review Days
78
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Basic Information
- Device Name
- IMA-TROL IMMUNOASSAY CONTROL
- K Number
- K844848
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Dimension Diagnostics
- Date Received
- December 13, 1984
- Decision Date
- March 1, 1985
- Product Code
- JJY
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 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 |
| K861366 | ALT-30, 60 AND 100 | Jun 25, 1986 | 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 |
| K844760 | UROL-QUAL | Jan 8, 1985 | Substantially Equivalent |
| K844709 | CRITIC-ARS | Jan 8, 1985 | Substantially Equivalent |