FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II
K Number: K872507
·
Decision Jul 9, 1987
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
108
Applicant Total
25
Review Days
15
Basic Information
- Device Name
- PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II
- K Number
- K872507
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- PRECISION DYNAMICS CORP.
- Date Received
- June 24, 1987
- Decision Date
- July 9, 1987
- Product Code
- JSM
- 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 |
|---|---|---|---|
| JSM | Culture Media, Non-Propagating Transport | FDA class 1 | Microbiology |
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