FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO-MONITOR GENTAMICIN
K Number: K780951
·
Decision Aug 14, 1978
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
6
Review Days
66
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Basic Information
- Device Name
- BIO-MONITOR GENTAMICIN
- K Number
- K780951
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3450
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Monitor Science Corp.
- Date Received
- June 9, 1978
- Decision Date
- August 14, 1978
- Product Code
- DKD
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| DKD | Bacillus Subtilis, Microbiological Assay, Gentamicin | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DKD), ordered by most recent decision date.
View allOther Clearances by Monitor Science Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K790580 | RIA KIT, PROSTATIC ACID | May 25, 1979 | Substantially Equivalent |
| K780949 | BIO-MONITOR AMIKACIN | Aug 14, 1978 | Substantially Equivalent |
| K780950 | BIO-MONITOR TOBRAMYCIN | Aug 14, 1978 | Substantially Equivalent |
| K772038 | KANAMYCIN RIA | Jan 12, 1978 | Substantially Equivalent |
| K772039 | BETA-HCG RIA | Nov 23, 1977 | Substantially Equivalent |