FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOTRACK PROTIME TEST PROTHROMBIN TIME TEST
K Number: K860721
·
Decision May 23, 1986
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
126
Applicant Total
16
Review Days
86
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Basic Information
- Device Name
- BIOTRACK PROTIME TEST PROTHROMBIN TIME TEST
- K Number
- K860721
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7750
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Biotrack, Inc.
- Date Received
- February 26, 1986
- Decision Date
- May 23, 1986
- Product Code
- GJS
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GJS | Test, Time, Prothrombin | FDA class 2 | Hematology |
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|---|---|---|---|
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| 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 |
| K900372 | BIOTRACK IMMUNOCHEMISTRY MONITOR | Feb 23, 1990 | Substantially Equivalent |
| K895101 | BIOTRACK HEMOGLOBIN TEST CARTRIDGE | Oct 10, 1989 | Substantially Equivalent |
| K895102 | BIOTRACK PDS MONITOR | Oct 10, 1989 | Substantially Equivalent |