FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECO HOMOCYSTEINE ENZYMATIC ASSAY
K Number: K063701
·
Decision Apr 11, 2007
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
28
Applicant Total
51
Review Days
119
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Basic Information
- Device Name
- TECO HOMOCYSTEINE ENZYMATIC ASSAY
- K Number
- K063701
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1377
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Teco Diagnostics
- Date Received
- December 13, 2006
- Decision Date
- April 11, 2007
- Product Code
- LPS
- 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 |
|---|---|---|---|
| LPS | Urinary Homocystine (Nonquantitative) Test System | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LPS), ordered by most recent decision date.
VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III
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AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100
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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 |
| K061419 | TECO MICROALBUMIN 2-1 COMBO STRIPS | Jan 26, 2007 | Substantially Equivalent |
| K061065 | FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25 | Jul 14, 2006 | Substantially Equivalent |