FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VIRAL CULTURETTE HANK'S BAL. SALT SOL.
K Number: K800832
·
Decision May 20, 1980
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
110
Applicant Total
2
Review Days
36
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Basic Information
- Device Name
- VIRAL CULTURETTE HANK'S BAL. SALT SOL.
- K Number
- K800832
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Marion Health & Safety, Inc.
- Date Received
- April 14, 1980
- Decision Date
- May 20, 1980
- 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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Other Clearances by Marion Health & Safety, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K792201 | STREP CULTURETTE | Nov 30, 1979 | Substantially Equivalent |