FDA 510(k)
FDA class 1
Substantially Equivalent
🇫🇮 Finland
ROTALEX
K Number: K860529
·
Decision Mar 4, 1986
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
32
Applicant Total
21
Review Days
21
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Basic Information
- Device Name
- ROTALEX
- K Number
- K860529
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3405
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Orion Corp.
- Date Received
- February 11, 1986
- Decision Date
- March 4, 1986
- Product Code
- LIQ
- 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 |
|---|---|---|---|
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LIQ), ordered by most recent decision date.
SAS ROTA TEST
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VIDAS ROTAVIRUS (RTV) ASSAY
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IMMUNOCARD STAT! ROTAVIRUS
FDA 510(k)
FDA Class 1
·Microbiology
ROTAVIRUS EIA
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VIDAS ROTAVIRUS ASSAY
FDA 510(k)
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·Microbiology
ROTA-DAN RAPID ROTAVIRUS EIA KIT
FDA 510(k)
FDA Class 1
·Microbiology
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 |
| K864457 | CHLAMYSET ANTIBODY EIA | Sep 11, 1987 | Substantially Equivalent |