FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CATH KIT, URINE SPECIMEN
K Number: K780167
·
Decision Feb 21, 1978
Classifications
1
FEI Numbers
294
Registration Numbers
294
Same Product Code
22
Applicant Total
645
Review Days
19
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Basic Information
- Device Name
- CATH KIT, URINE SPECIMEN
- K Number
- K780167
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3250
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- C.R. Bard, Inc.
- Date Received
- February 2, 1978
- Decision Date
- February 21, 1978
- Product Code
- FMH
- Advisory Committee
- Pathology
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMH | Container, Specimen, Sterile | FDA class 1 | Pathology |
Similar 510(k) Clearances
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URINE SPECIMEN CONTAINER #'S 1013-1016
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