FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOCULT - GC CULTURE-PADDLES
K Number: K831124
·
Decision May 9, 1983
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
82
Applicant Total
28
Review Days
34
Basic Information
- Device Name
- BIOCULT - GC CULTURE-PADDLES
- K Number
- K831124
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.2410
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- ORION DIAGNOSTICA, INC.
- Date Received
- April 5, 1983
- Decision Date
- May 9, 1983
- Product Code
- JTY
- 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 |
|---|---|---|---|
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | FDA class 2 | Microbiology |
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|---|---|---|---|
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| K884147 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M | Oct 27, 1988 | Substantially Equivalent |
| K884074 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G | Oct 27, 1988 | Substantially Equivalent |
| K884040 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A | Oct 19, 1988 | Substantially Equivalent |
| K884075 | IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN | 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 |