FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RSL'S ASSAY PROCEDURE QUANTITATION
K Number: K791728
·
Decision Sep 27, 1979
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
41
Applicant Total
15
Review Days
28
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Basic Information
- Device Name
- RSL'S ASSAY PROCEDURE QUANTITATION
- K Number
- K791728
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1265
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Radioassay Systems Laboratories, Inc.
- Date Received
- August 30, 1979
- Decision Date
- September 27, 1979
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CGI), ordered by most recent decision date.
UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
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ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA
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ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL
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COAT-A-COUNT FREE ESTRIOL
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AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT
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FDA Class 1
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AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Radioassay Systems Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K862204 | RSL (125I) ALDOSTERONE KIT | Sep 25, 1986 | Substantially Equivalent |
| K842960 | ANDROSTENEDIONE BY RIA | Sep 27, 1984 | Substantially Equivalent |
| K840886 | HYDROXYPROGESTERONE BY RIA 17A | Apr 18, 1984 | Substantially Equivalent |
| K831855 | HATCH KIT | Jul 28, 1983 | Substantially Equivalent |
| K802195 | DEHYDROEPIANDROSTERONE SULFATE KIT RIA | Oct 23, 1980 | Substantially Equivalent |
| K800126 | RSL (125 L) PROGESTERONE KIT | Feb 13, 1980 | Substantially Equivalent |
| K791999 | (125I) TESTOSTERONE KIT | Oct 30, 1979 | Substantially Equivalent |
| K791651 | TOTAL ESTROGENS KIT BY RIA | Sep 27, 1979 | Substantially Equivalent |
| K791740 | SERUM 11-DESOXYCORTISOL I AS TRACER | Sep 27, 1979 | Substantially Equivalent |
| K791835 | CORALENT COAT 125I CORTISOL RADIOIMM. | Sep 27, 1979 | Substantially Equivalent |