FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RESPIRACULT-STREP DEEP BED CULTURE PAD
K Number: K821659
·
Decision Aug 5, 1982
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
145
Applicant Total
28
Review Days
62
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Basic Information
- Device Name
- RESPIRACULT-STREP DEEP BED CULTURE PAD
- K Number
- K821659
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Orion Diagnostica, Inc.
- Date Received
- June 4, 1982
- Decision Date
- August 5, 1982
- Product Code
- JSH
- 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 |
|---|---|---|---|
| JSH | Culture Media, Non-Selective And Differential | 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 |
| 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 |