FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LYPHOCHEK SERUM REF. STANDARD-BOVINE
K Number: K832695
·
Decision Oct 4, 1983
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
301
Applicant Total
319
Review Days
55
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
- LYPHOCHEK SERUM REF. STANDARD-BOVINE
- K Number
- K832695
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Bio-Rad
- Date Received
- August 10, 1983
- Decision Date
- October 4, 1983
- Product Code
- JIX
- 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIX), ordered by most recent decision date.
VITROS Chemistry Products Calibrator Kit 3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYSTEM CALIBRATER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Bio-Rad
| K Number | Device Name | ||
|---|---|---|---|
| K171061 | MRSASelect II | Dec 28, 2017 | Substantially Equivalent |
| K122187 | VRESELECT CULTURE MEDIUM | Nov 6, 2012 | Substantially Equivalent |
| K103684 | VRESELECT CULTURE MEDIUM | Oct 21, 2011 | Substantially Equivalent |
| K093678 | PLATELIA ASPERGILLUS EIA MODEL 62793 | Jan 13, 2011 | Substantially Equivalent |
| K100589 | MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS | Oct 29, 2010 | Substantially Equivalent |
| K081362 | PLATELIA LYME IGM | Jun 26, 2008 | Substantially Equivalent |
| K081212 | MRSASELECT - EXTENDED INCUBATION | Jun 13, 2008 | Substantially Equivalent |
| K080012 | PLATELIA LYME IGG ASSAY | May 8, 2008 | Substantially Equivalent |
| K070361 | MRSASELECT | Sep 13, 2007 | Substantially Equivalent |
| K060641 | PLATELIA ASPERGILLUS EIA, MODEL 62793 | Jun 2, 2006 | Substantially Equivalent |