510(k) K100790
- Device
- COULTER LIN-X LINEARITY CONTROL, MODEL A81196
- Applicant
- BECKMAN COULTER, INC.
- 510(k) number
- K100790
- Product code
- JPK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-12-21
- Date received
- 2010-03-22
- Regulation
- 864.8625
- Classification name
- Mixture, Hematology Quality Control
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LOURDES M COBA
- Address
- 11800 SW 147th Ave. M/S 31-B06 Miami FL US 33196 33196
FDA Registration Numbers#
- 2249801
- 3013660430
- 1064608
- 3007603826
- 3017448032
- 3005333358
- 3003741796
- 2432235
- 3008352382
- 1938095
- 9613959
- 3014150341
- 2020715
- 3010939897
- 3009711478
- 3027394506
- 1950302
- 3008311438
- 1827821
- 1061932
- 2016706
- 1017835
- 2182501
- 1217058
- 1220649
- 1616487
- 3023162659
- 1219029
- 2221819
- 1064130
- 3000148879
- 3010127294
Source Documents#
Other 510(k) Records For Product Code JPK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K160590 | XN CHECK | Streck | 2016-12-22 |
| K160588 | XN CHECK BF | Streck | 2016-12-22 |
| K160586 | XN-L CHECK | Streck | 2016-12-22 |
| K160606 | BC-5D Hematology Control | R&D Systems, Inc. | 2016-09-01 |
| K141964 | XN CHECK | Streck | 2014-12-05 |
| K141957 | XN CHECK BF | Streck | 2014-12-05 |
| K130962 | R&D 5D RETIC HEMATOLOGY CONTROL | R&D Systems, Inc. | 2013-07-24 |
| K120744 | XN CHECK BF | Streck | 2012-10-19 |
| K120742 | XN CHECK | Streck | 2012-10-19 |
| K101578 | R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL | R&D Systems, Inc. | 2011-04-28 |
| K100607 | COULTER 4C-EX 300 CELL CONTROL | Beckman Coulter, Inc. | 2010-11-18 |
| K091303 | LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV | Bio-Rad Laboratories | 2010-08-02 |
| K100050 | R & D SYSTEMS XERET HEMATOLOGY CONTROL | R&D Systems, Inc. | 2010-01-29 |
| K091433 | R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL | R&D Systems, Inc. | 2009-10-28 |
| K090201 | UA-CELLULAR FOR IQ | Streck | 2009-03-27 |
Legacy Summary#
summary
FDA Review#
Decision Summary