FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLYCATED PROTEIN CALIBRATORS
K Number: K940008
·
Decision May 9, 1994
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
129
Applicant Total
11
Review Days
125
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Basic Information
- Device Name
- GLYCATED PROTEIN CALIBRATORS
- K Number
- K940008
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Primus Corp.
- Date Received
- January 4, 1994
- Decision Date
- May 9, 1994
- Product Code
- JIS
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JIS | Calibrator, Primary | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K013787 | NYCOCARD CRP | May 14, 2002 | Substantially Equivalent |
| K014084 | NYCOCARD CRP CONTROL | Jan 7, 2002 | Substantially Equivalent |
| K994045 | PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 | Dec 21, 1999 | Substantially Equivalent |
| K992921 | PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II | Nov 12, 1999 | Substantially Equivalent |
| K955283 | PRIMUS VARIANT SYSTEM PVS99 | Mar 1, 1996 | Substantially Equivalent |
| K942009 | PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY | Sep 14, 1994 | Substantially Equivalent |
| K940142 | GLYCATED PROTEIN CONTROLS | Apr 26, 1994 | Substantially Equivalent |
| K936204 | GLYCATED HEMOGLOBIN CALIBRATORS | Mar 22, 1994 | Substantially Equivalent |
| K940143 | GLYCATED HEMOGLOBIN CONTROLS | Mar 15, 1994 | Substantially Equivalent |