FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CATHRA GRAM POSITIVE SCREEN
K Number: K874606
·
Decision May 6, 1988
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
10
Applicant Total
3
Review Days
179
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Basic Information
- Device Name
- CATHRA GRAM POSITIVE SCREEN
- K Number
- K874606
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Mct Medical, Inc.
- Date Received
- November 9, 1987
- Decision Date
- May 6, 1988
- 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 |
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