FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
P AND T MEDIUM
K Number: K904773
·
Decision Dec 4, 1990
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
42
Applicant Total
4
Review Days
43
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- P AND T MEDIUM
- K Number
- K904773
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2900
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Gibson Laboratories, Inc.
- Date Received
- October 22, 1990
- Decision Date
- December 4, 1990
- 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
Other 510(k) clearances with the same product code (JTW), ordered by most recent decision date.
COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
GEN-PROBE APTIMA COMBO 2 ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)
FDA 510(k)
FDA Class 1
·Microbiology