Dade Hematology Calibrator
FDA 510(k) K831140 · American Dade
510(k) numberK831140
Submission
- Device name
- Dade Hematology Calibrator
- Applicant
- American Dade
Mchenry, IL, US - Received
- April 7, 1983
- Decision date
- June 8, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRX – Calibrator For Cell Indices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8150
- Specialty
- Hematology
Other 510(k)s with product code KRX
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|---|---|---|---|
| K160585 | XN CalKRX · Traditional | Streck | 12/22/2016SE |
| K141962 | XN CalKRX · Traditional | Streck | 12/05/2014SE |
| K141955 | XN Cal PFKRX · Traditional | Streck | 12/05/2014SE |
| K120747 | XN Cal PFKRX · Traditional | Streck | 10/22/2012SE |
| K120745 | XN CalKRX · Traditional | Streck | 10/19/2012SE |
| K111204 | Cell-Dyn 22 Plus CalibratorKRX · Traditional | Streck | 12/22/2011SE |
| K083200 | X-CalKRX · Traditional | Streck | 02/03/2009SE |
| K020469 | Cal-Chex CD PlusKRX · Traditional | Streck Laboratories, Inc. | 04/04/2002SE |
| K003991 | Cd-Cal Plus CalibratorKRX · Special | R&D Systems, Inc. | 01/16/2001SE |
| K993375 | CDS LTX Control Latex Particle Suspension and PrimerKRX · Abbreviated | Clinical Diagnostic Solutions, Inc. | 12/20/1999SE |
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Questions and answers
When was Dade Hematology Calibrator cleared by the FDA?
Dade Hematology Calibrator (K831140) received a 510(k) decision of Substantially Equivalent on June 8, 1983, 62 days after the submission was received.
What is the product code of K831140?
The FDA product code is KRX – Calibrator For Cell Indices, a Class II (moderate risk) device regulated under 21 CFR 864.8150.