FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402
K Number: K090475
·
Decision Apr 16, 2009
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
23
Review Days
51
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Basic Information
- Device Name
- VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402
- K Number
- K090475
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Maine Standards Co.
- Date Received
- February 24, 2009
- Decision Date
- April 16, 2009
- Product Code
- JJY
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Maine Standards Co.
| K Number | Device Name | ||
|---|---|---|---|
| K123127 | VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 | Jun 14, 2013 | Substantially Equivalent |
| K113524 | VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT | Jan 27, 2012 | Substantially Equivalent |
| K103271 | MSC LIPID CONTROL | Jan 25, 2011 | Substantially Equivalent |
| K091225 | VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET | Jun 25, 2009 | Substantially Equivalent |
| K083891 | VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 | Mar 23, 2009 | Substantially Equivalent |
| K082067 | MSC LIPID CONTROL | Aug 22, 2008 | Substantially Equivalent |
| K072246 | VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601 | Sep 14, 2007 | Substantially Equivalent |
| K062501 | VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901 | Sep 29, 2006 | Substantially Equivalent |
| K053247 | VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET | Jan 13, 2006 | Substantially Equivalent |
| K050504 | VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS | Mar 25, 2005 | Substantially Equivalent |