FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOTRACK IMMUNOCHEMISTRY MONITOR
K Number: K900372
·
Decision Feb 23, 1990
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
16
Review Days
28
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Basic Information
- Device Name
- BIOTRACK IMMUNOCHEMISTRY MONITOR
- K Number
- K900372
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biotrack, Inc.
- Date Received
- January 26, 1990
- Decision Date
- February 23, 1990
- Product Code
- JJQ
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Biotrack, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K934061 | BIOTRACK VALPROIC ACID TEST CARTRIDGE | Dec 29, 1993 | Substantially Equivalent |
| K934062 | BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS | Dec 29, 1993 | Substantially Equivalent |
| K920525 | BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL | Aug 5, 1992 | Substantially Equivalent |
| K915755 | BIOTRACK PHENYTOIN TEST CARTRIDGE | Jul 23, 1992 | Substantially Equivalent |
| K915756 | BIOTRACK CARBAMAZEPINE TEST CARTRIDGE | Jul 23, 1992 | Substantially Equivalent |
| K903924 | BIOTRACK THEOPHYLLINE QUALITY CONTROLS | Sep 17, 1990 | Substantially Equivalent |
| K900373 | BIOTRACK THEOPHYLLINE TEST CARTRIDGE | May 30, 1990 | Substantially Equivalent |
| K895101 | BIOTRACK HEMOGLOBIN TEST CARTRIDGE | Oct 10, 1989 | Substantially Equivalent |
| K895102 | BIOTRACK PDS MONITOR | Oct 10, 1989 | Substantially Equivalent |
| K895128 | BIOTRACK ALT TEST CARTRIDGE | Oct 6, 1989 | Substantially Equivalent |