FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE
K Number: K861361
·
Decision Jun 27, 1986
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
49
Applicant Total
25
Review Days
78
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Basic Information
- Device Name
- ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE
- K Number
- K861361
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1260
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Serono Diagnostics, Inc.
- Date Received
- April 10, 1986
- Decision Date
- June 27, 1986
- 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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ACS ESTADIOL-6 II
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VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)
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FDA Class 1
·Clinical Chemistry
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Serono Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K953598 | SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS | Mar 11, 1996 | Substantially Equivalent |
| K942051 | SR1 DHEA-S ENZYME IMMUNOASSAY | Jul 13, 1994 | Substantially Equivalent |
| K883085 | T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS | Sep 9, 1988 | Substantially Equivalent |
| K882340 | LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA | Aug 8, 1988 | Substantially Equivalent |
| K880388 | T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE | Mar 3, 1988 | Substantially Equivalent |
| K874866 | T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE | Feb 11, 1988 | Substantially Equivalent |
| K873431 | PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH | Oct 20, 1987 | Substantially Equivalent |
| K873186 | LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA | Sep 29, 1987 | Substantially Equivalent |
| K873400 | PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA | Sep 25, 1987 | Substantially Equivalent |
| K872862 | PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS | Sep 18, 1987 | Substantially Equivalent |