FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENDAB ESTRIOL UNCONJUGATED
K Number: K840902
·
Decision Apr 18, 1984
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
41
Applicant Total
37
Review Days
50
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Basic Information
- Device Name
- ENDAB ESTRIOL UNCONJUGATED
- K Number
- K840902
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1265
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Immunotech Corp.
- Date Received
- February 28, 1984
- Decision Date
- April 18, 1984
- Product Code
- CGI
- 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 |
|---|---|---|---|
| CGI | Radioimmunoassay, Estriol | FDA class 1 | Clinical Chemistry |
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|---|---|---|---|
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| K931228 | PROGESTERONE RADIOIMMUNOASSAY KIT | Oct 22, 1993 | Substantially Equivalent |
| K911634 | MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST | Jun 24, 1991 | Substantially Equivalent |
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| K910411 | MICROZYME TSH ENZYME IMMUNOASSAY KIT | Apr 3, 1991 | Substantially Equivalent |
| K905777 | MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT | Jan 30, 1991 | Substantially Equivalent |
| K903993 | MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT | Dec 20, 1990 | Substantially Equivalent |
| K904820 | MICROZYME T3 ENZYME IMMUNOASSAY KIT | Dec 18, 1990 | Substantially Equivalent |