FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ADENOLEX (R) LATEX AGGLUTINATION TEST
K Number: K864645
·
Decision Jun 4, 1987
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
10
Applicant Total
28
Review Days
191
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Basic Information
- Device Name
- ADENOLEX (R) LATEX AGGLUTINATION TEST
- K Number
- K864645
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3020
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Orion Diagnostica, Inc.
- Date Received
- November 25, 1986
- Decision Date
- June 4, 1987
- Product Code
- GOD
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| GOD | Antigens, Cf (Including Cf Control), Adenovirus 1-33 | FDA class 1 | Microbiology |
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Other Clearances by Orion Diagnostica, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942286 | DIARLEX ROTA-ADENO | Dec 14, 1994 | Substantially Equivalent |
| K914892 | SALIVA-STIM | Sep 2, 1992 | Substantially Equivalent |
| K904655 | PYLORISET | Oct 21, 1991 | Substantially Equivalent |
| K884074 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G | Oct 27, 1988 | Substantially Equivalent |
| 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 |
| 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 |