FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH
K Number: K941433
·
Decision Aug 2, 1994
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
492
Applicant Total
41
Review Days
131
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Basic Information
- Device Name
- HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH
- K Number
- K941433
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hichem Diagnostics
- Date Received
- March 24, 1994
- Decision Date
- August 2, 1994
- Product Code
- JJX
- 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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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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 |
| K953860 | HICHEM ISE DILUENT KIT 70008 | 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 |
| K925612 | HI CHEM ELECTROLYTE BUFFER | Apr 20, 1993 | Substantially Equivalent |