FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TROBICIN SUSCEPTIBILITY POWDER
K Number: K902004
·
Decision May 15, 1990
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
6
Review Days
39
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Basic Information
- Device Name
- TROBICIN SUSCEPTIBILITY POWDER
- K Number
- K902004
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- The Upjohn Co.
- Date Received
- April 6, 1990
- Decision Date
- May 15, 1990
- Product Code
- LOP
- 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 |
|---|---|---|---|
| LOP | Solution, Antimicrobial | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LOP), ordered by most recent decision date.
ZEFAZONE SUSCEPTIBILITY POWDER
FDA 510(k)
FDA Class 2
·Microbiology
STOCK ANTIMICROBIC SOLUTIONS
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by The Upjohn Co.
| K Number | Device Name | ||
|---|---|---|---|
| K900455 | ZEFAZONE SUSCEPTIBILITY POWDER | Feb 9, 1990 | Substantially Equivalent |
| K810853 | CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT | May 29, 1981 | Substantially Equivalent |
| K782009 | RIA KIT, PROGESTERONE | Mar 2, 1979 | Substantially Equivalent |
| K780792 | TESTOSTERONE RADIOIMMUNOASSAY KIT 125I | Jun 13, 1978 | Substantially Equivalent |
| K760920 | CAT-A-KIT | Nov 9, 1976 | Substantially Equivalent |