FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMUBEAD T4 ENZYME IMMUNOASSAY KIT
K Number: K872192
·
Decision Aug 13, 1987
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
85
Applicant Total
37
Review Days
66
Basic Information
- Device Name
- IMMUBEAD T4 ENZYME IMMUNOASSAY KIT
- K Number
- K872192
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- IMMUNOTECH CORP.
- Date Received
- June 8, 1987
- Decision Date
- August 13, 1987
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLI), ordered by most recent decision date.
VITROS® Automation Solutions
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GSP NEONATAL THYROXINE (T4)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS TOTAL T4 ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by IMMUNOTECH CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K954188 | OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL | Nov 3, 1995 | Substantially Equivalent |
| K952789 | OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES | Aug 14, 1995 | Substantially Equivalent |
| K950626 | OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES | May 5, 1995 | Substantially Equivalent |
| K931228 | PROGESTERONE RADIOIMMUNOASSAY KIT | Oct 22, 1993 | Substantially Equivalent |
| K911634 | MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST | Jun 24, 1991 | Substantially Equivalent |
| K911153 | MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT | Jun 18, 1991 | Substantially Equivalent |
| K910411 | MICROZYME TSH ENZYME IMMUNOASSAY KIT | Apr 3, 1991 | Substantially Equivalent |
| K905777 | MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT | Jan 30, 1991 | Substantially Equivalent |
| K903993 | MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT | Dec 20, 1990 | Substantially Equivalent |
| K904820 | MICROZYME T3 ENZYME IMMUNOASSAY KIT | Dec 18, 1990 | Substantially Equivalent |