FDA 510(k)
FDA class 1
Substantially Equivalent
🇫🇮 Finland
CHLAMYSET ANTIBODY EIA
K Number: K864457
·
Decision Sep 11, 1987
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
66
Applicant Total
21
Review Days
303
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Basic Information
- Device Name
- CHLAMYSET ANTIBODY EIA
- K Number
- K864457
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3120
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Orion Corp.
- Date Received
- November 12, 1986
- Decision Date
- September 11, 1987
- Product Code
- LJC
- 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 |
|---|---|---|---|
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | FDA class 1 | Microbiology |
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Other Clearances by Orion Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K912391 | RUBALEX, MODIFICATION | May 4, 1992 | Substantially Equivalent |
| K901637 | RESUBMITTED MODIFIED RUBALEX | Apr 26, 1990 | Substantially Equivalent |
| K884650 | RESUBMITTED SCANORA | Mar 16, 1989 | Substantially Equivalent |
| K890199 | DENTOCULT SM-STRIP MUTANS | Mar 2, 1989 | Substantially Equivalent |
| K881506 | MAMEX DC MAG MG12 | Jun 10, 1988 | Substantially Equivalent |
| K881505 | MAMEX DC MG11 | Jun 10, 1988 | Substantially Equivalent |
| K874040 | MAMEX DC S SL10/MG14 | Nov 23, 1987 | Substantially Equivalent |
| K872744 | MODIFIED CHLAMYSET ANTIGEN | Sep 22, 1987 | Substantially Equivalent |
| K872301 | DENTOCULT-SM CULTURE-PADDLE | Sep 11, 1987 | Substantially Equivalent |
| K872058 | ORICULT-N CULTURE-PADDLE | Jun 10, 1987 | Substantially Equivalent |