FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORTISOL RIA KIT
K Number: K822892
·
Decision Nov 1, 1982
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
83
Applicant Total
16
Review Days
34
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Basic Information
- Device Name
- CORTISOL RIA KIT
- K Number
- K822892
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1205
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Antibodies, Inc.
- Date Received
- September 28, 1982
- Decision Date
- November 1, 1982
- 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 Antibodies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K890774 | GIARDEIA(TM) | Apr 4, 1989 | Substantially Equivalent |
| K843590 | DETECT-A-STREP | Oct 30, 1984 | Substantially Equivalent |
| K812749 | ULTRA-DIG | Oct 19, 1981 | Substantially Equivalent |
| K812314 | CRITHIDNA ANTI-DNA TEST KIT | Sep 1, 1981 | Substantially Equivalent |
| K802877 | AMIKACIN RIA KIT | Dec 19, 1980 | Substantially Equivalent |
| K800743 | TOBRAMYCIN RIA KIT | Apr 16, 1980 | Substantially Equivalent |
| K791217 | TSH RIA KIT | Sep 4, 1979 | Substantially Equivalent |
| K781655 | NEPHELRATE ANTISERUMS 1GA | Nov 8, 1978 | Substantially Equivalent |
| K781654 | NEPHELRATE ANTIPERUMS LGM | Nov 8, 1978 | Substantially Equivalent |
| K781656 | NEPHELRATE ANTISERUMS, IGG | Nov 8, 1978 | Substantially Equivalent |