FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PTH MR
K Number: K831470
·
Decision Jun 22, 1983
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
85
Applicant Total
9
Review Days
47
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
- PTH MR
- K Number
- K831470
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1545
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Ramco Laboratories, Inc.
- Date Received
- May 6, 1983
- Decision Date
- June 22, 1983
- Product Code
- CEW
- 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 |
|---|---|---|---|
| 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 Ramco Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983107 | VFE | Oct 22, 1998 | Substantially Equivalent |
| K981208 | TFR | Oct 21, 1998 | Substantially Equivalent |
| K910481 | EPO-RIA | Nov 29, 1991 | Substantially Equivalent |
| K872941 | SPECTRO C | Sep 4, 1987 | Substantially Equivalent |
| K864701 | VWF IMMUNOBLOT | Mar 30, 1987 | Substantially Equivalent |
| K861159 | SPECTRO VWF | May 1, 1986 | Substantially Equivalent |
| K823016 | CANDIDA DETECTION SYSTEM | Dec 28, 1982 | Substantially Equivalent |
| K812056 | SPECTRO FEIRITIN | Aug 12, 1981 | Substantially Equivalent |