FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OREIA-Q-TY, ENZYME IMMUNOASSAY
K Number: K802693
·
Decision Dec 10, 1980
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
85
Applicant Total
41
Review Days
41
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Basic Information
- Device Name
- OREIA-Q-TY, ENZYME IMMUNOASSAY
- K Number
- K802693
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Organon, Inc.
- Date Received
- October 30, 1980
- Decision Date
- December 10, 1980
- 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 Organon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K950861 | RECONSTITUTION ACCESSOREIS | May 26, 1995 | Substantially Equivalent |
| K853388 | MONOSTICON UNI-DOT | Aug 22, 1985 | Substantially Equivalent |
| K842314 | DUOCLON COLOR-CEPT | Aug 24, 1984 | Substantially Equivalent |
| K841525 | OREIA II B-HCG PREGNANCY TEST KIT | Jun 5, 1984 | Substantially Equivalent |
| K841602 | ACCURATE BETA 30 PREGNANCY TEST KIT | May 22, 1984 | Substantially Equivalent |
| K840650 | B-NEOCEPT 30 | Apr 4, 1984 | Substantially Equivalent |
| K832801 | OREIA II B-HCG, ENZYME INNUNOASSAY | Dec 8, 1983 | Substantially Equivalent |
| K831339 | NEO-PREGNOSTICON DUOCLON TUBE TEST | Jun 8, 1983 | Substantially Equivalent |
| K831109 | DUOCLON SLIDE TEST | Jun 2, 1983 | Substantially Equivalent |
| K823682 | BETA FFIRM TEST | Jan 7, 1983 | Substantially Equivalent |