FDA 510(k)
FDA class 1
Substantially Equivalent
🇫🇮 Finland
SALIVA-STIM
K Number: K914892
·
Decision Sep 2, 1992
Classifications
1
FEI Numbers
198
Registration Numbers
198
Same Product Code
24
Applicant Total
28
Review Days
307
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Basic Information
- Device Name
- SALIVA-STIM
- K Number
- K914892
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6890
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Orion Diagnostica, Inc.
- Date Received
- October 31, 1991
- Decision Date
- September 2, 1992
- Product Code
- EGD
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| EGD | Wax, Dental, Intraoral | FDA class 1 | Dental |
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Other Clearances by Orion Diagnostica, Inc.
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|---|---|---|---|
| K942286 | DIARLEX ROTA-ADENO | Dec 14, 1994 | Substantially Equivalent |
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| K884147 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M | Oct 27, 1988 | Substantially Equivalent |
| K884075 | IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN | Oct 19, 1988 | Substantially Equivalent |
| K884040 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A | Oct 19, 1988 | Substantially Equivalent |
| K864645 | ADENOLEX (R) LATEX AGGLUTINATION TEST | Jun 4, 1987 | Substantially Equivalent |
| K871196 | RHEUMA-CHECK ENZYME IMMUNOASSAY TEST | May 6, 1987 | Substantially Equivalent |
| K862475 | RESPIRASTICK ENZYME IMMUNOASSAY TEST | Sep 16, 1986 | Substantially Equivalent |
| K854129 | ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS | Jan 21, 1986 | Substantially Equivalent |