FDA 510(k)
FDA class 1
Substantially Equivalent
🇫🇮 Finland
DENTOCULT-SM CULTURE-PADDLE
K Number: K872301
·
Decision Sep 11, 1987
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
21
Review Days
88
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Basic Information
- Device Name
- DENTOCULT-SM CULTURE-PADDLE
- K Number
- K872301
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Orion Corp.
- Date Received
- June 15, 1987
- Decision Date
- September 11, 1987
- Product Code
- JSI
- 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 |
|---|---|---|---|
| JSI | Culture Media, Selective And Differential | 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 |
| K864457 | CHLAMYSET ANTIBODY EIA | Sep 11, 1987 | Substantially Equivalent |
| K872058 | ORICULT-N CULTURE-PADDLE | Jun 10, 1987 | Substantially Equivalent |