FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECHNICON DAX SYSTEM THYROXINE (T4) METHOD
K Number: K922945
·
Decision Oct 14, 1992
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
120
Applicant Total
145
Review Days
118
Basic Information
- Device Name
- TECHNICON DAX SYSTEM THYROXINE (T4) METHOD
- K Number
- K922945
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- HERAEUS KULZER, INC.
- Date Received
- June 18, 1992
- Decision Date
- October 14, 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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TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
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STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO
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·Clinical Chemistry
Other Clearances by HERAEUS KULZER, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K091494 | FLEXITIME FLOW | Jul 31, 2009 | Substantially Equivalent |
| K063062 | HKBOND 2006 | Dec 1, 2006 | Substantially Equivalent |
| K060994 | MONDIAL | May 22, 2006 | Substantially Equivalent |
| K052543 | HERACERAM ZIRKONIA | Oct 25, 2005 | Substantially Equivalent |
| K043504 | PALAIMPACT | Jan 28, 2005 | Substantially Equivalent |
| K043295 | VERSYO.DIRECT | Jan 5, 2005 | Substantially Equivalent |
| K042878 | FLEXITIME XTREME | Dec 17, 2004 | Substantially Equivalent |
| K030052 | OSTIM | Dec 6, 2004 | Substantially Equivalent |
| K040859 | HERACERAM PRESS | May 20, 2004 | Substantially Equivalent |
| K040043 | NDX-40 ALLOY | Mar 3, 2004 | Substantially Equivalent |