FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
JEMBEC TRANSPORT SYSTEM
K Number: K811283
·
Decision Jun 12, 1981
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
42
Applicant Total
6
Review Days
35
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Basic Information
- Device Name
- JEMBEC TRANSPORT SYSTEM
- K Number
- K811283
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2900
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Biolog, Inc.
- Date Received
- May 8, 1981
- Decision Date
- June 12, 1981
- Product Code
- JTW
- 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 |
|---|---|---|---|
| JTW | System, Transport, Aerobic | FDA class 1 | Microbiology |
Similar 510(k) Clearances
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Other Clearances by Biolog, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K850751 | DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY | May 23, 1985 | Substantially Equivalent |
| K850750 | DISPOSABLE UROSTOMY POUCH | May 23, 1985 | Substantially Equivalent |
| K811282 | SELECTIVE GC CULTURE MEDIUM | Jun 12, 1981 | Substantially Equivalent |
| K811281 | GC CULTURE MEDIUM | Jun 12, 1981 | Substantially Equivalent |
| K811284 | GC TTANSPORT SYSTEM | Jun 12, 1981 | Substantially Equivalent |