FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
URINE REAGENT STRIPS-8 PARAMETERS
K Number: K943436
·
Decision Apr 24, 1995
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
4
Applicant Total
51
Review Days
280
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
- URINE REAGENT STRIPS-8 PARAMETERS
- K Number
- K943436
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1115
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Teco Diagnostics
- Date Received
- July 18, 1994
- Decision Date
- April 24, 1995
- Product Code
- JJB
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JJB | Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJB), ordered by most recent decision date.
BIOSCAN REAGENT STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
WAKO(TM) PRETEST 8A
FDA 510(k)
FDA Class 1
·Clinical Chemistry
URINE DIAGNOSTIC REAGENT STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
REAGENT TESTS STRIP COMBINATIONS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Teco Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K170118 | Scanostics UTI Check Application Test System | Sep 21, 2017 | Substantially Equivalent |
| K141289 | TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS | Jul 24, 2015 | Substantially Equivalent |
| K131600 | URS-2GP (GLUCOSE PROTEIN) URINE STRIPS | May 29, 2014 | Substantially Equivalent |
| K111206 | TECO DIAGNOSTICS SALIVA ALCOHOL TEST | Oct 4, 2011 | Substantially Equivalent |
| K100024 | TECO DIAGNOSTICS UTI DETECTION STRIPS | Feb 17, 2011 | Substantially Equivalent |
| K101673 | URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 | Feb 4, 2011 | Substantially Equivalent |
| K073370 | TC MATRIX CLINICAL CHEMISTRY ANALYZER | May 8, 2008 | Substantially Equivalent |
| K072548 | CREATINE KINASE LIQUID REAGENT, MODEL C519-440 | Apr 18, 2008 | Substantially Equivalent |
| K063701 | TECO HOMOCYSTEINE ENZYMATIC ASSAY | Apr 11, 2007 | Substantially Equivalent |
| K061419 | TECO MICROALBUMIN 2-1 COMBO STRIPS | Jan 26, 2007 | Substantially Equivalent |