FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTRAY GC
K Number: K993033
·
Decision Dec 16, 1999
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
82
Applicant Total
2
Review Days
98
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Basic Information
- Device Name
- INTRAY GC
- K Number
- K993033
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.2410
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomed Diagnostics, Inc.
- Date Received
- September 9, 1999
- Decision Date
- December 16, 1999
- Product Code
- JTY
- 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 |
|---|---|---|---|
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | FDA class 2 | Microbiology |
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Other Clearances by Biomed Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K896296 | INPOUCH-TV POUCH | Jan 29, 1990 | Substantially Equivalent |