FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Q-CHECK CULTI-LOOPS
K Number: K830133
·
Decision Feb 9, 1983
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
11
Applicant Total
5
Review Days
27
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Basic Information
- Device Name
- Q-CHECK CULTI-LOOPS
- K Number
- K830133
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2480
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Lab Ability, Inc.
- Date Received
- January 13, 1983
- Decision Date
- February 9, 1983
- Product Code
- JTR
- Advisory Committee
- Microbiology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JTR | Kit, Quality Control For Culture Media | FDA class 1 | Microbiology |
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