FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT
K Number: K992845
·
Decision Oct 18, 1999
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
301
Applicant Total
12
Review Days
55
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Basic Information
- Device Name
- HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT
- K Number
- K992845
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elan Holdings, Inc.
- Date Received
- August 24, 1999
- Decision Date
- October 18, 1999
- 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 |
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Other Clearances by Elan Holdings, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K013152 | ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS | Nov 9, 2001 | Substantially Equivalent |
| K012474 | ATAC PAK CPK REAGENT KIT | Oct 3, 2001 | Substantially Equivalent |
| K010488 | ATAC PAK AST REAGENT KIT | Apr 9, 2001 | Substantially Equivalent |
| K000958 | ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS | May 24, 2000 | Substantially Equivalent |
| K000900 | ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS | May 2, 2000 | Substantially Equivalent |
| K992842 | HICHEM ISE ELECTROLYTE REFERENCE | Nov 26, 1999 | Substantially Equivalent |
| K992844 | HICHEM ISE ELECTROLYTE BUFFER | Nov 26, 1999 | Substantially Equivalent |
| K992846 | HICHEM TOTAL PROTEIN REAGENT | Oct 18, 1999 | Substantially Equivalent |
| K992847 | HICHEM BUN REAGENT | Oct 14, 1999 | Substantially Equivalent |
| K991789 | ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS | Jul 9, 1999 | Substantially Equivalent |