FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEPHELRATE ANTIPERUMS LGM
K Number: K781654
·
Decision Nov 8, 1978
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
60
Applicant Total
16
Review Days
42
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Basic Information
- Device Name
- NEPHELRATE ANTIPERUMS LGM
- K Number
- K781654
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Antibodies, Inc.
- Date Received
- September 27, 1978
- Decision Date
- November 8, 1978
- Product Code
- CFN
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | FDA class 2 | Immunology |
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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 |
| K822892 | CORTISOL RIA KIT | Nov 1, 1982 | 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 |
| K781656 | NEPHELRATE ANTISERUMS, IGG | Nov 8, 1978 | Substantially Equivalent |