FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST)
K Number: K860719
·
Decision May 23, 1986
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
180
Applicant Total
16
Review Days
86
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Basic Information
- Device Name
- BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST)
- K Number
- K860719
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Biotrack, Inc.
- Date Received
- February 26, 1986
- Decision Date
- May 23, 1986
- Product Code
- JPA
- 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 |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | FDA class 2 | Hematology |
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|---|---|---|---|
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| 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 |
| 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 |