FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOTRACK PHENYTOIN TEST CARTRIDGE
K Number: K915755
·
Decision Jul 23, 1992
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
43
Applicant Total
16
Review Days
213
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BIOTRACK PHENYTOIN TEST CARTRIDGE
- K Number
- K915755
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3350
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biotrack, Inc.
- Date Received
- December 23, 1991
- Decision Date
- July 23, 1992
- Product Code
- DIP
- 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 |
|---|---|---|---|
| DIP | Enzyme Immunoassay, Diphenylhydantoin | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DIP), ordered by most recent decision date.
ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ROCHE ONLINE TDM PHENYTOIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RANDOX PHENYTOIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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 |
| 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 |
| K895128 | BIOTRACK ALT TEST CARTRIDGE | Oct 6, 1989 | Substantially Equivalent |