FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONOSTICON UNI-DOT
K Number: K853388
·
Decision Aug 22, 1985
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
58
Applicant Total
41
Review Days
9
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Basic Information
- Device Name
- MONOSTICON UNI-DOT
- K Number
- K853388
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5640
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Organon, Inc.
- Date Received
- August 13, 1985
- Decision Date
- August 22, 1985
- Product Code
- KTN
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| KTN | System, Test, Infectious Mononucleosis | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KTN), ordered by most recent decision date.
OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
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DRYSPOT INFECTIOUS MONONUCLEOSIS KIT
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CLEARVIEW IM
FDA 510(k)
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Other Clearances by Organon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K950861 | RECONSTITUTION ACCESSOREIS | May 26, 1995 | 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 |
| K812967 | ACCURATE BETA | Nov 6, 1981 | Substantially Equivalent |