510(k) K003991
- Device
- CD-CAL PLUS CALIBRATOR
- Applicant
- R & D SYSTEMS, INC.
- 510(k) number
- K003991
- Product code
- KRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-01-16
- Date received
- 2000-12-26
- Regulation
- 864.8150
- Classification name
- Calibrator For Cell Indices
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KENNETH T EDDS
- Address
- 614 Mckinley Pl. NE Minneapolis MN US 55413 55413
FDA Registration Numbers#
- 1061932
- 3007603826
- 1950302
- 3008311438
- 9613959
- 1064608
- 3014150341
- 2221819
- 3000148879
- 2182501
- 3009711478
- 3016438761
- 3005333358
- 3003741796
- 2432235
Source Documents#
Other 510(k) Records For Product Code KRX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K160585 | XN CAL | Streck | 2016-12-22 |
| K141955 | XN CAL PF | Streck | 2014-12-05 |
| K141962 | XN CAL | Streck | 2014-12-05 |
| K120747 | XN CAL PF | Streck | 2012-10-22 |
| K120745 | XN CAL | Streck | 2012-10-19 |
| K111204 | CELL-DYN 22 PLUS CALIBRATOR | Streck | 2011-12-22 |
| K083200 | X-CAL | Streck | 2009-02-03 |
| K020469 | CAL-CHEX CD PLUS | Streck Laboratories, Inc. | 2002-04-04 |
| K993375 | CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER | Clinical Diagnostic Solutions, Inc. | 1999-12-20 |
| K955925 | CBC-CAL PLUS HEMATOLOGY CALIBRATOR | R&D Systems, Inc. | 1996-02-29 |
| K912357 | 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE | R&D Systems, Inc. | 1991-07-09 |
| K862858 | CBC-CAL (TM) PLUS/MULTIPLE | R&D Systems, Inc. | 1986-08-21 |
| K831140 | DADE HEMATOLOGY CALIBRATOR | American Dade | 1983-06-08 |
| K811741 | CELL-CHEX RBC | Streck Laboratories, Inc. | 1981-09-24 |
| K811063 | LASER-CAL | Diagnostic Technology, Inc. | 1981-07-01 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases