FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HUMAN PLACENTAL LACTOGEN RADIOIMMUNO-
K Number: K810625
·
Decision Mar 27, 1981
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
10
Review Days
18
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Basic Information
- Device Name
- HUMAN PLACENTAL LACTOGEN RADIOIMMUNO-
- K Number
- K810625
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.5065
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Serono Laboratories, Inc.
- Date Received
- March 9, 1981
- Decision Date
- March 27, 1981
- Product Code
- DHI
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| DHI | Ng3m(Bo), Antigen, Antiserum, Control | FDA class 1 | Immunology |
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 |
| 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 |
| K781285 | INSULIN RIA KIT | Aug 14, 1978 | Substantially Equivalent |