FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE
K Number: K883765
·
Decision Oct 31, 1988
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
92
Applicant Total
15
Review Days
55
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Basic Information
- Device Name
- TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE
- K Number
- K883765
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1715
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biotecx Laboratories, Inc.
- Date Received
- September 6, 1988
- Decision Date
- October 31, 1988
- Product Code
- KHQ
- 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 |
|---|---|---|---|
| KHQ | Radioassay, Triiodothyronine Uptake | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K893620 | T3 CLASP-BEAD EIA KIT | Aug 11, 1989 | Substantially Equivalent |
| K892853 | T4 CLASP-BEAD EIA KIT | May 22, 1989 | Substantially Equivalent |
| K871211 | PROGESTERONE CLASP RADIOIMMUNOASSAY KIT | Apr 13, 1987 | Substantially Equivalent |
| K863188 | HPL RIA KIT | Sep 25, 1986 | Substantially Equivalent |
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| K851540 | ESTRADIOL DIRECT RIA KIT | Jun 6, 1985 | Substantially Equivalent |
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