FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACTH II BY RADIOIMMUNOASSAY
K Number: K850882
·
Decision Mar 21, 1985
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
29
Applicant Total
30
Review Days
17
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Basic Information
- Device Name
- ACTH II BY RADIOIMMUNOASSAY
- K Number
- K850882
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1025
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Immuno Nuclear Corp.
- Date Received
- March 4, 1985
- Decision Date
- March 21, 1985
- Product Code
- CKG
- 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 |
|---|---|---|---|
| CKG | Radioimmunoassay, Acth | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
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ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
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ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011
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ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100
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FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT
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Other Clearances by Immuno Nuclear Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K863743 | BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT | Dec 15, 1986 | Substantially Equivalent |
| K863973 | ELM ALLERGEN DISC | Dec 1, 1986 | Substantially Equivalent |
| K863844 | IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISC | Oct 29, 1986 | Substantially Equivalent |
| K863123 | IMMUNO BIOTECH MUGWART ALLERGEN DISC | Oct 1, 1986 | Substantially Equivalent |
| K863098 | MEADOW FESCUE ALLERGEN DISC | Sep 15, 1986 | Substantially Equivalent |
| K862266 | MAPLE ALLERGEN DISC | Aug 19, 1986 | Substantially Equivalent |
| K862938 | JUNE GRASS ALLERGEN DISC | Aug 15, 1986 | Substantially Equivalent |
| K862176 | RUSSIAN THISTLE ALLERGEN DISC | Aug 15, 1986 | Substantially Equivalent |
| K862265 | COTTONWOOD ALLERGEN DISC | Aug 15, 1986 | Substantially Equivalent |
| K862939 | ORCHARD GRASS ALLERGEN DISC | Aug 15, 1986 | Substantially Equivalent |