FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICROMEDIC ESTRIOL RIA KIT
K Number: K822578
·
Decision Oct 26, 1982
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
41
Applicant Total
42
Review Days
62
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Basic Information
- Device Name
- MICROMEDIC ESTRIOL RIA KIT
- K Number
- K822578
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1265
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Micromedic Systems
- Date Received
- August 25, 1982
- Decision Date
- October 26, 1982
- 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
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AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL
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Other Clearances by Micromedic Systems
| K Number | Device Name | ||
|---|---|---|---|
| K923643 | MEDICOOL | Mar 31, 1993 | Substantially Equivalent |
| K872309 | MICROMEDIC COMBOSTAT LH/FSH KIT | Jul 31, 1987 | Substantially Equivalent |
| K871505 | AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT | May 26, 1987 | Substantially Equivalent |
| K871008 | MICROMEDIC NEONATAL T4 KIT | May 26, 1987 | Substantially Equivalent |
| K870904 | MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT | May 26, 1987 | Substantially Equivalent |
| K870245 | AUTOPAK TSH MONOCLONAL IRMA KIT | Apr 1, 1987 | Substantially Equivalent |
| K862206 | TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER | Aug 4, 1986 | Substantially Equivalent |
| K860813 | MICROMEDIC HTSH MONOCLONAL IRMA KIT | Jul 14, 1986 | Substantially Equivalent |
| K861262 | MMS T3 UPTAKE | May 23, 1986 | Substantially Equivalent |
| K861320 | MMS T4 RIA KIT | Apr 24, 1986 | Substantially Equivalent |