FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTICOAT T4 EIA KIT
K Number: K982298
·
Decision Feb 3, 1999
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
85
Applicant Total
15
Review Days
217
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Basic Information
- Device Name
- OPTICOAT T4 EIA KIT
- K Number
- K982298
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biotecx Laboratories, Inc.
- Date Received
- July 1, 1998
- Decision Date
- February 3, 1999
- 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 Biotecx Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981824 | OPTICOAT T3 EIA KIT | Dec 22, 1998 | Substantially Equivalent |
| K895407 | CORTISOL CLASP-BEAD EIA KIT | Oct 19, 1989 | Substantially Equivalent |
| K893620 | T3 CLASP-BEAD EIA KIT | Aug 11, 1989 | Substantially Equivalent |
| K892853 | T4 CLASP-BEAD EIA KIT | May 22, 1989 | Substantially Equivalent |
| K883765 | TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE | Oct 31, 1988 | Substantially Equivalent |
| K871211 | PROGESTERONE CLASP RADIOIMMUNOASSAY KIT | Apr 13, 1987 | Substantially Equivalent |
| K863188 | HPL RIA KIT | Sep 25, 1986 | Substantially Equivalent |
| K854876 | ALDOSTERONE DIRECT RIA KIT | Mar 17, 1986 | Substantially Equivalent |
| K851540 | ESTRADIOL DIRECT RIA KIT | Jun 6, 1985 | Substantially Equivalent |
| K844767 | RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO | Feb 1, 1985 | Substantially Equivalent |