FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO-MONITOR AMIKACIN
K Number: K780949
·
Decision Aug 14, 1978
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
3
Applicant Total
6
Review Days
66
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Basic Information
- Device Name
- BIO-MONITOR AMIKACIN
- K Number
- K780949
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3035
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Monitor Science Corp.
- Date Received
- June 9, 1978
- Decision Date
- August 14, 1978
- Product Code
- KLP
- 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 |
|---|---|---|---|
| KLP | Amikacin Serum Assay | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLP), ordered by most recent decision date.
ONLINE TDM AMIKA
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BACTEC
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Monitor Science Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K790580 | RIA KIT, PROSTATIC ACID | May 25, 1979 | Substantially Equivalent |
| K780950 | BIO-MONITOR TOBRAMYCIN | Aug 14, 1978 | Substantially Equivalent |
| K780951 | BIO-MONITOR GENTAMICIN | Aug 14, 1978 | Substantially Equivalent |
| K772038 | KANAMYCIN RIA | Jan 12, 1978 | Substantially Equivalent |
| K772039 | BETA-HCG RIA | Nov 23, 1977 | Substantially Equivalent |