FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DELFIA(TM) TRIIODOTHYRONINE (T3) KIT
K Number: K864452
·
Decision Feb 2, 1987
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
143
Applicant Total
52
Review Days
82
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Basic Information
- Device Name
- DELFIA(TM) TRIIODOTHYRONINE (T3) KIT
- K Number
- K864452
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1710
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Lkb Instruments, Inc.
- Date Received
- November 12, 1986
- Decision Date
- February 2, 1987
- Product Code
- CDP
- 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 |
|---|---|---|---|
| CDP | Radioimmunoassay, Total Triiodothyronine | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDP), ordered by most recent decision date.
REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)
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TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005
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OPTICOAT T3 EIA KIT
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ABBOTT ARCHITECT FREE T3
FDA 510(k)
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Other Clearances by Lkb Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K874094 | 1205 BETAPLATE LIQUID SCINTILLATION COUNTER | Nov 4, 1987 | Substantially Equivalent |
| K872955 | DELFIA(TM) FERRITIN KIT | Aug 21, 1987 | Substantially Equivalent |
| K871303 | DELFIA(TM) THYROXINE (T4) KIT | Jun 17, 1987 | Substantially Equivalent |
| K871599 | DELFIA(TM) HIGE KIT | Jun 12, 1987 | Substantially Equivalent |
| K871644 | DELFIA (TM) HTSH KIT | May 12, 1987 | Substantially Equivalent |
| K864733 | LKB 2260 MACROTOME | Jan 5, 1987 | Substantially Equivalent |
| K862848 | LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 | Dec 18, 1986 | Substantially Equivalent |
| K863422 | DELFIA(TM) CORTISOL KIT | Sep 26, 1986 | Substantially Equivalent |
| K861195 | DELFIA DIGOXIN | Jul 11, 1986 | Substantially Equivalent |
| K862044 | DELFIA (TM) HCG KIT | Jul 11, 1986 | Substantially Equivalent |