FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOTRACK PDS MONITOR
K Number: K895102
·
Decision Oct 10, 1989
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
16
Review Days
56
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 PDS MONITOR
- K Number
- K895102
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biotrack, Inc.
- Date Received
- August 15, 1989
- Decision Date
- October 10, 1989
- Product Code
- JJQ
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJQ), ordered by most recent decision date.
UBIT-IR300 INFRARED SPECTROMETRY SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIGENE DML 2000 MICROPLATE LUMINOMETER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
STAT TRACKS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ANTHOS PHACTS VERSION MICROPLATE READER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CBI 7520 READER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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 |
| K900372 | BIOTRACK IMMUNOCHEMISTRY MONITOR | Feb 23, 1990 | Substantially Equivalent |
| K895101 | BIOTRACK HEMOGLOBIN TEST CARTRIDGE | Oct 10, 1989 | Substantially Equivalent |
| K895128 | BIOTRACK ALT TEST CARTRIDGE | Oct 6, 1989 | Substantially Equivalent |