FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
K Number: K936016
·
Decision Jul 19, 1994
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
19
Applicant Total
79
Review Days
215
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
- QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
- K Number
- K936016
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7250
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- R&D Systems, Inc.
- Date Received
- December 16, 1993
- Decision Date
- July 19, 1994
- Product Code
- GGT
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| GGT | Assay, Erythropoietin | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GGT), ordered by most recent decision date.
Access EPO
FDA 510(k)
FDA Class 2
·Hematology
ADVIA Centaur Erythropoietin (EPO) assay
FDA 510(k)
FDA Class 2
·Hematology
ACCESS EPO ASSAY
FDA 510(k)
FDA Class 2
·Hematology
SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT
FDA 510(k)
FDA Class 2
·Hematology
IMMULITE EPO, MODEL #'S LKEPZ & LKEP1
FDA 510(k)
FDA Class 2
·Hematology
ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by R&D Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K160606 | BC-5D Hematology Control | Sep 1, 2016 | Substantially Equivalent |
| K130962 | R&D 5D RETIC HEMATOLOGY CONTROL | Jul 24, 2013 | Substantially Equivalent |
| K101578 | R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL | Apr 28, 2011 | Substantially Equivalent |
| K100050 | R & D SYSTEMS XERET HEMATOLOGY CONTROL | Jan 29, 2010 | Substantially Equivalent |
| K091433 | R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL | Oct 28, 2009 | Substantially Equivalent |
| K073178 | HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 | Dec 27, 2007 | Substantially Equivalent |
| K072846 | CSF AUTOMATED CONTROL, MODELS CSF001, CSF003 | Nov 26, 2007 | Substantially Equivalent |
| K072268 | HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S | Nov 20, 2007 | Substantially Equivalent |
| K072096 | CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04 | Aug 20, 2007 | Substantially Equivalent |
| K070334 | R&D SICKLE QC CONTROL | Mar 29, 2007 | Substantially Equivalent |