FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMPLEMENT C3 NEPHELOMETRIC ASSAY
K Number: K772249
·
Decision Dec 22, 1977
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
85
Applicant Total
92
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
- COMPLEMENT C3 NEPHELOMETRIC ASSAY
- K Number
- K772249
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1545
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Kallestad Laboratories, Inc.
- Date Received
- December 9, 1977
- Decision Date
- December 22, 1977
- Product Code
- CEW
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| CEW | Radioimmunoassay, Parathyroid Hormone | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CEW), ordered by most recent decision date.
Elecsys PTH , Elecsys PTH STAT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Access Intact PTH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Lumipulse G whole PTH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IDS-iSYS Intact PTHN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Kallestad Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K863681 | PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM | Dec 3, 1986 | Substantially Equivalent |
| K862917 | PATHFINDER ROTAVIRUS CHEMILUMINESCENT | Oct 22, 1986 | Substantially Equivalent |
| K863682 | PATHFINDER(TM) SPECIMEN COLLECTION KIT | Oct 10, 1986 | Substantially Equivalent |
| K862743 | PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS | Sep 29, 1986 | Substantially Equivalent |
| K862313 | KALLESTAD SM/RNP TEST REAGENT | Aug 6, 1986 | Substantially Equivalent |
| K862710 | KALLESTAD SSA/SSB ENA TEST REAGENTS | Jul 29, 1986 | Substantially Equivalent |
| K855014 | QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A | Mar 14, 1986 | Substantially Equivalent |
| K855010 | QUANTIMETRIC PLUS IGM REAGENT KIT | Feb 28, 1986 | Substantially Equivalent |
| K855009 | QUANTIMETRIC PLUS IGA REAGENT KIT | Feb 26, 1986 | Substantially Equivalent |
| K855008 | QUANTIMETRIC PLUS KAPPA REAGENT KIT | Feb 26, 1986 | Substantially Equivalent |