510(k) K993375
- Device
- CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER
- Applicant
- CLINICAL DIAGNOSTIC SOLUTIONS, INC.
- 510(k) number
- K993375
- Product code
- KRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-12-20
- Date received
- 1999-10-07
- Regulation
- 864.8150
- Classification name
- Calibrator For Cell Indices
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- COLIN ALDERSLEY
- Address
- 1660 NW 65th Ave. Suite 2 Plantation FL US 33313 33313
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 |
| K003991 | CD-CAL PLUS CALIBRATOR | R&D Systems, Inc. | 2001-01-16 |
| 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#
summary
FDA Review#
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