FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.
K Number: K896329
·
Decision Dec 12, 1989
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
85
Applicant Total
12
Review Days
40
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Basic Information
- Device Name
- D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.
- K Number
- K896329
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Photec Diagnostics, Inc.
- Date Received
- November 2, 1989
- Decision Date
- December 12, 1989
- Product Code
- KLI
- 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 |
|---|---|---|---|
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | FDA class 2 | Clinical Chemistry |
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Other Clearances by Photec Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K897169 | QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT | Feb 23, 1990 | Substantially Equivalent |
| K894057 | QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT | Aug 31, 1989 | Substantially Equivalent |
| K892224 | D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN | Jun 16, 1989 | Substantially Equivalent |
| K890267 | QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA | Apr 26, 1989 | Substantially Equivalent |
| K890027 | QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD | Apr 26, 1989 | Substantially Equivalent |
| K882307 | D-CHEM | Aug 2, 1988 | Substantially Equivalent |
| K880291 | THEOPHYLLINE TEST KIT REF. #A874799 | Mar 24, 1988 | Substantially Equivalent |
| K854875 | APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 | Jan 24, 1986 | Substantially Equivalent |
| K853048 | APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 | Aug 28, 1985 | Substantially Equivalent |
| K853174 | APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN | Aug 22, 1985 | Substantially Equivalent |