FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KAPPA SERUM (FREE) ANTI-HUMAN
K Number: K781027
·
Decision Jul 27, 1978
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
62
Applicant Total
48
Review Days
38
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Basic Information
- Device Name
- KAPPA SERUM (FREE) ANTI-HUMAN
- K Number
- K781027
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5550
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Icl Scientific
- Date Received
- June 19, 1978
- Decision Date
- July 27, 1978
- Product Code
- DFH
- 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 |
|---|---|---|---|
| DFH | Kappa, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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Other Clearances by Icl Scientific
| K Number | Device Name | ||
|---|---|---|---|
| K883942 | HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL | Nov 10, 1988 | Substantially Equivalent |
| K843565 | KOVA TROL I,II, III HUMAN URINE-DRIED | Oct 5, 1984 | Substantially Equivalent |
| K833761 | THERAPEUTIC DRUG CONTROL | Jan 13, 1984 | Substantially Equivalent |
| K832823 | ENZYMUNE-TEST TSH | Oct 14, 1983 | Substantially Equivalent |
| K831383 | EVENT-TEST SLIDE | Jun 22, 1983 | Substantially Equivalent |
| K823199 | ENZYME-TEST DIGOXIN | Nov 29, 1982 | Substantially Equivalent |
| K822346 | HISTIMUNE ENZYME-ANA TEST | Oct 8, 1982 | Substantially Equivalent |
| K822777 | THERAPEUTIC DRUG CONTROL | Oct 8, 1982 | Substantially Equivalent |
| K822465 | ENZYMUNE SYSTEM I | Sep 14, 1982 | Substantially Equivalent |
| K821374 | ENZYMUNE-TEST INSULIN | May 28, 1982 | Substantially Equivalent |