FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMES TDA/TOBRAMYCIN
K Number: K791435
·
Decision Aug 16, 1979
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
22
Applicant Total
158
Review Days
16
Basic Information
- Device Name
- AMES TDA/TOBRAMYCIN
- K Number
- K791435
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3900
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- MILES LABORATORIES, INC.
- Date Received
- July 31, 1979
- Decision Date
- August 16, 1979
- Product Code
- KLB
- 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 |
|---|---|---|---|
| KLB | Radioimmunoassay, Tobramycin | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLB), ordered by most recent decision date.
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Other Clearances by MILES LABORATORIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K880605 | LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER | May 26, 1988 | Substantially Equivalent |
| K874909 | MICRO-BUMINTEST REAGENT TABLETS | Apr 28, 1988 | Substantially Equivalent |
| K875079 | MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE | Apr 5, 1988 | Substantially Equivalent |
| K871835 | GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT | Dec 22, 1987 | Substantially Equivalent |
| K872120 | SERALYZER III BLOOD CHEMISTRY ANALYZER | Oct 28, 1987 | Substantially Equivalent |
| K873304 | CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) | Sep 11, 1987 | Substantially Equivalent |
| K872634 | CUTTER PUREFLO PLUS IV FILTER | Aug 4, 1987 | Substantially Equivalent |
| K870214 | MODIFIED SALTEX REAGENT STRIPS | Jun 29, 1987 | Substantially Equivalent |
| K870752 | SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS | Apr 14, 1987 | Substantially Equivalent |
| K865053 | SERA-TEK MICROSOMAL ANTIBODY TEST | Feb 18, 1987 | Substantially Equivalent |