FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
T4 EIA BEAD ASSAY
K Number: K920766
·
Decision Apr 17, 1992
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
120
Applicant Total
36
Review Days
58
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Basic Information
- Device Name
- T4 EIA BEAD ASSAY
- K Number
- K920766
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tech-Co, Inc.
- Date Received
- February 19, 1992
- Decision Date
- April 17, 1992
- Product Code
- CDX
- 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 |
|---|---|---|---|
| CDX | Radioimmunoassay, Total Thyroxine | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDX), ordered by most recent decision date.
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AXSYM(TM) TOTAL T4
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TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Tech-Co, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K921968 | IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST | Jun 28, 1996 | Substantially Equivalent |
| K923376 | VISUAL HCG PREGNANCY TEST | Oct 1, 1992 | Substantially Equivalent |
| K920716 | DIRECT PREGNANCY TEST | Mar 24, 1992 | Substantially Equivalent |
| K902574 | POTASSIUM REAGENT SET | Jul 10, 1990 | Substantially Equivalent |
| K901561 | IRON/TOTAL IRON BINDING CAPACITY | May 17, 1990 | Substantially Equivalent |
| K883387 | ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) | Oct 13, 1988 | Substantially Equivalent |
| K883683 | HEMOGLOBIN | Oct 6, 1988 | Substantially Equivalent |
| K883386 | CHLORIDE | Oct 6, 1988 | Substantially Equivalent |
| K881172 | BILIRUBIN (DIRECT) | Jun 7, 1988 | Substantially Equivalent |
| K881173 | ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) | Jun 7, 1988 | Substantially Equivalent |