FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VISI-STREP
K Number: K910537
·
Decision Apr 12, 1991
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
10
Applicant Total
2
Review Days
63
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Basic Information
- Device Name
- VISI-STREP
- K Number
- K910537
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Kev Connecticut Diagnostics, Inc.
- Date Received
- February 8, 1991
- Decision Date
- April 12, 1991
- Product Code
- LQL
- 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 |
|---|---|---|---|
| LQL | Gram Positive Identification Panel | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LQL), ordered by most recent decision date.
GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90
FDA 510(k)
FDA Class 1
·Microbiology
RAPID GRAM-POSITIVE ID SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
BBLCRYSTAL GRAM-POSITIVE ID SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)
FDA 510(k)
FDA Class 1
·Microbiology
VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD
FDA 510(k)
FDA Class 1
·Microbiology
RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Kev Connecticut Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K913456 | VISI-NEISSERIA | Oct 11, 1991 | Substantially Equivalent |