FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ESTRADIOL RIA KIT
K Number: K790679
·
Decision May 23, 1979
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
49
Applicant Total
10
Review Days
44
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Basic Information
- Device Name
- ESTRADIOL RIA KIT
- K Number
- K790679
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1260
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Serono Laboratories, Inc.
- Date Received
- April 9, 1979
- Decision Date
- May 23, 1979
- Product Code
- CHP
- 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 |
|---|---|---|---|
| CHP | Radioimmunoassay, Estradiol | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CHP), ordered by most recent decision date.
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ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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 |
| 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 |