FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMER. BIO-SCIENCE LAB CORTISOL REAGENT
K Number: K842455
·
Decision Aug 16, 1984
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
83
Applicant Total
2
Review Days
55
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Basic Information
- Device Name
- AMER. BIO-SCIENCE LAB CORTISOL REAGENT
- K Number
- K842455
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1205
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- American Bio-Science Laboratories
- Date Received
- June 22, 1984
- Decision Date
- August 16, 1984
- Product Code
- CGR
- 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 |
|---|---|---|---|
| CGR | Radioimmunoassay, Cortisol | FDA class 2 | Clinical Chemistry |
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Other Clearances by American Bio-Science Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K842590 | AMER. BIO-SCIENCE LAB T3 REAGENTS | Aug 10, 1984 | Substantially Equivalent |