FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HICHEM ISE DILUENT KIT 70008
K Number: K953860
·
Decision Sep 6, 1995
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
37
Applicant Total
41
Review Days
20
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
- HICHEM ISE DILUENT KIT 70008
- K Number
- K953860
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1170
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hichem Diagnostics
- Date Received
- August 17, 1995
- Decision Date
- September 6, 1995
- Product Code
- CGZ
- 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 |
|---|---|---|---|
| CGZ | Electrode, Ion-Specific, Chloride | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CGZ), ordered by most recent decision date.
VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Alinity c ICT Sample Diluent
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VITROS Chemistry Products Cl- Slides
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Hichem Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K981794 | HICHEM CALCIUM REAGENT KIT | Jul 29, 1998 | Substantially Equivalent |
| K963383 | HICHEM ALP/AMP REAGENT KIT | Sep 23, 1996 | Substantially Equivalent |
| K953862 | HICHEM ISEKCI SOLUTION KIT 70010 | Sep 6, 1995 | Substantially Equivalent |
| K953861 | HICHEM ISE INTDERNAL REFERENCE KIT 70009 | Sep 6, 1995 | Substantially Equivalent |
| K953863 | HICHEM ISE STANDARDS KIT 70011 | Sep 6, 1995 | Substantially Equivalent |
| K951751 | HICHEM AST REAGENT KIT | Aug 2, 1995 | Substantially Equivalent |
| K946192 | HICHEM Y-GT REAGENT KIT | May 2, 1995 | Substantially Equivalent |
| K946022 | HICHEM LDH/L REAGENT KIT | Feb 23, 1995 | Substantially Equivalent |
| K941433 | HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH | Aug 2, 1994 | Substantially Equivalent |
| K925612 | HI CHEM ELECTROLYTE BUFFER | Apr 20, 1993 | Substantially Equivalent |