FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOSIL HOMOCYSTEINE AND CONTROLS
K Number: K061598
·
Decision Sep 22, 2006
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
28
Applicant Total
321
Review Days
106
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
- HEMOSIL HOMOCYSTEINE AND CONTROLS
- K Number
- K061598
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1377
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instrumentation Laboratory CO
- Date Received
- June 8, 2006
- Decision Date
- September 22, 2006
- 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
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIAZYME HOMOCYSTEINE POC TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HOMOCYSTEINE TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Instrumentation Laboratory CO
| K Number | Device Name | ||
|---|---|---|---|
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM | Sep 29, 2023 | Substantially Equivalent |
| K223187 | HemosIL Liquid Anti-Xa | Jun 23, 2023 | Substantially Equivalent |
| K223090 | GEM Premier ChemSTAT | Jan 27, 2023 | Substantially Equivalent |
| K223402 | HemosIL von Willebrand Factor Antigen | Dec 9, 2022 | Substantially Equivalent |
| K213464 | HemosIL Liquid Anti-Xa | Oct 4, 2022 | Substantially Equivalent |
| K213426 | HemosIL ReadiPlasTin | Aug 16, 2022 | Substantially Equivalent |
| K203790 | GEM Premier 5000 | Aug 20, 2021 | Substantially Equivalent |
| DEN190032 | HemosIL Liquid Anti-Xa | Sep 17, 2020 | Unknown |
| K200033 | HemosIL von Willebrand Factor Antigen | Aug 19, 2020 | Substantially Equivalent |
| K183549 | GEM Premier ChemSTAT | Feb 16, 2019 | Substantially Equivalent |