FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUANTEX ASO-CRP-RF CONTROL
K Number: K971777
·
Decision May 27, 1997
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
96
Applicant Total
321
Review Days
13
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
- QUANTEX ASO-CRP-RF CONTROL
- K Number
- K971777
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instrumentation Laboratory CO
- Date Received
- May 14, 1997
- Decision Date
- May 27, 1997
- Product Code
- JJT
- 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 |
|---|---|---|---|
| JJT | Enzyme Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJT), ordered by most recent decision date.
SPOTCHECK BLOOD SPOT CONTROL, ASSAYED
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
FDA 510(k)
FDA Class 1
·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 |