FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THERMOMETER, SINGLE USE, STRIP, TEMPADOT
K Number: K771038
·
Decision Jun 27, 1977
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
13
Applicant Total
41
Review Days
17
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Basic Information
- Device Name
- THERMOMETER, SINGLE USE, STRIP, TEMPADOT
- K Number
- K771038
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.2900
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Organon, Inc.
- Date Received
- June 10, 1977
- Decision Date
- June 27, 1977
- Product Code
- FQZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FQZ | Thermometer, Clinical Color Change | FDA class 1 | General Hospital |
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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 |