FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SAS ROTA TEST
K Number: K990842
·
Decision Aug 9, 1999
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
32
Applicant Total
199
Review Days
147
Basic Information
- Device Name
- SAS ROTA TEST
- K Number
- K990842
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3405
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- SA SCIENTIFIC, INC.
- Date Received
- March 15, 1999
- Decision Date
- August 9, 1999
- 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
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Other Clearances by SA SCIENTIFIC, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K100227 | SAS FLUALERT A&B, SAS INFLUENZA A TEST | Feb 23, 2010 | Substantially Equivalent |
| K080380 | SAS INFLUENZA A & B TEST | Jul 23, 2009 | Substantially Equivalent |
| K041439 | SAS INFLUENZA B TEST | Jul 22, 2004 | Substantially Equivalent |
| K041441 | SAS INFLUENZA A TEST | Jul 22, 2004 | Substantially Equivalent |
| K030628 | SAS RSV CONTROL KIT | Mar 17, 2003 | Substantially Equivalent |
| K022845 | SAS RSV TEST | Jan 29, 2003 | Substantially Equivalent |
| K022683 | SAS BLOOD/SERUM/URINE/URINE HCG | Dec 16, 2002 | Substantially Equivalent |
| K023270 | SAS STREPALERT | Oct 17, 2002 | Substantially Equivalent |
| K020438 | SAS VALUE HCG | Mar 8, 2002 | Substantially Equivalent |
| K013379 | SAS STREPALERT | Dec 12, 2001 | Substantially Equivalent |