FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INSULIN RIA KIT
K Number: K781285
·
Decision Aug 14, 1978
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
26
Applicant Total
10
Review Days
19
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Basic Information
- Device Name
- INSULIN RIA KIT
- K Number
- K781285
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1405
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Serono Laboratories, Inc.
- Date Received
- July 26, 1978
- Decision Date
- August 14, 1978
- Product Code
- CFP
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| CFP | Radioimmunoassay, Immunoreactive Insulin | FDA class 1 | Clinical Chemistry |
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Other Clearances by Serono Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K834428 | ALDOSTERONE RADIOIMMUNOASSAY TEST KIT | Mar 2, 1984 | Substantially Equivalent |
| K810695 | ESTRIOL RADIOIMMUNOASSAY TEST KIT | Mar 31, 1981 | Substantially Equivalent |
| K810625 | HUMAN PLACENTAL LACTOGEN RADIOIMMUNO- | Mar 27, 1981 | Substantially Equivalent |
| K792043 | PAP-CHECK RIA KIT | Oct 30, 1979 | Substantially Equivalent |
| K790679 | ESTRADIOL RIA KIT | May 23, 1979 | Substantially Equivalent |
| K790440 | PROGESTERONE | May 3, 1979 | Substantially Equivalent |
| K782143 | RIA KIT, GLUCOSE | Feb 22, 1979 | Substantially Equivalent |
| K782103 | RIA KIT, NEONATAL T4 | Jan 17, 1979 | Substantially Equivalent |
| K781733 | RIA KIT, PREG-STAT | Dec 20, 1978 | Substantially Equivalent |