FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTOPAK 12 T3 RIA TEST DELIVERY SYSTEM
K Number: K791375
·
Decision Oct 11, 1979
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
143
Applicant Total
42
Review Days
79
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Basic Information
- Device Name
- AUTOPAK 12 T3 RIA TEST DELIVERY SYSTEM
- K Number
- K791375
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1710
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Micromedic Systems
- Date Received
- July 24, 1979
- Decision Date
- October 11, 1979
- Product Code
- CDP
- 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 |
|---|---|---|---|
| CDP | Radioimmunoassay, Total Triiodothyronine | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDP), ordered by most recent decision date.
REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)
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CHIRON DIAGNOSTICS ACS: 180 FT3
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TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005
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AIA-PACK FT3 ASSAY
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OPTICOAT T3 EIA KIT
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ABBOTT ARCHITECT FREE T3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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 |