FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SALMONELLA I.D.
K Number: K821338
·
Decision May 28, 1982
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
68
Applicant Total
57
Review Days
23
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Basic Information
- Device Name
- SALMONELLA I.D.
- K Number
- K821338
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3550
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Analytical Products, Inc.
- Date Received
- May 5, 1982
- Decision Date
- May 28, 1982
- Product Code
- GRM
- 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 |
|---|---|---|---|
| GRM | Antisera, All Groups, Salmonella Spp. | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GRM), ordered by most recent decision date.
SAS SALMONELLA O FACTOR 14 ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
SAS SALMONELLA O POLY B ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
SAS SALMONELLA H Z42 ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS
FDA 510(k)
FDA Class 2
·Microbiology
SAS SALMONELLA H Z4, Z24 ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
SAS SALMONELLA O FACTOR 20 ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Analytical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K924814 | API 20E/UNISCEPT 20E | Mar 11, 1993 | Substantially Equivalent |
| K923684 | API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC | Dec 3, 1992 | Substantially Equivalent |
| K922926 | API UNISCEPT KB/TYPE 2 AND 3 | Oct 13, 1992 | Substantially Equivalent |
| K901559 | MODIFICATION TO API UNISCEPT 20GP | Sep 10, 1990 | Substantially Equivalent |
| K901390 | DMAC INDOLE REAGENT | Apr 16, 1990 | Substantially Equivalent |
| K895796 | API UNISCEPT KB | Nov 13, 1989 | Substantially Equivalent |
| K884510 | MODIFICATION MICRO-MIC | Nov 22, 1988 | Substantially Equivalent |
| K884509 | MODIFICATION MIC/API UNISCEPT(R) | Nov 22, 1988 | Substantially Equivalent |
| K880598 | MODIFICATIONS TO API UNISCEPT (R) KB | Mar 23, 1988 | Substantially Equivalent |
| K874466 | API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC | Dec 9, 1987 | Substantially Equivalent |