FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOTRACK THEOPHYLLINE TEST CARTRIDGE
K Number: K900373
·
Decision May 30, 1990
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
70
Applicant Total
16
Review Days
124
Basic Information
- Device Name
- BIOTRACK THEOPHYLLINE TEST CARTRIDGE
- K Number
- K900373
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3880
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- BIOTRACK, INC.
- Date Received
- January 26, 1990
- Decision Date
- May 30, 1990
- Product Code
- KLS
- 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 |
|---|---|---|---|
| KLS | Enzyme Immunoassay, Theophylline | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
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Other Clearances by BIOTRACK, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K934062 | BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS | Dec 29, 1993 | Substantially Equivalent |
| K934061 | BIOTRACK VALPROIC ACID TEST CARTRIDGE | Dec 29, 1993 | Substantially Equivalent |
| K920525 | BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL | Aug 5, 1992 | Substantially Equivalent |
| K915756 | BIOTRACK CARBAMAZEPINE TEST CARTRIDGE | Jul 23, 1992 | Substantially Equivalent |
| K915755 | BIOTRACK PHENYTOIN TEST CARTRIDGE | Jul 23, 1992 | Substantially Equivalent |
| K903924 | BIOTRACK THEOPHYLLINE QUALITY CONTROLS | Sep 17, 1990 | Substantially Equivalent |
| K900372 | BIOTRACK IMMUNOCHEMISTRY MONITOR | Feb 23, 1990 | Substantially Equivalent |
| K895102 | BIOTRACK PDS MONITOR | Oct 10, 1989 | Substantially Equivalent |
| K895101 | BIOTRACK HEMOGLOBIN TEST CARTRIDGE | Oct 10, 1989 | Substantially Equivalent |
| K895128 | BIOTRACK ALT TEST CARTRIDGE | Oct 6, 1989 | Substantially Equivalent |