510(k) K891175
- Device
- EDL ABNORMAL COAGULATION CONTROL
- Applicant
- ELITE DIAGNOSTIC LTD.
- 510(k) number
- K891175
- Product code
- GGL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-04-10
- Date received
- 1989-03-06
- Regulation
- 864.8625
- Classification name
- Control, White-cell
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROY SPECK
- Address
- 3244 Dogwood Cir. So. Dr. Indianapolis IN US 46268 46268
FDA Registration Numbers#
- 1950302
- 3014150341
- 1017835
- 1061932
- 3027394506
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GGL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K083926 | CD4 COUNT | Streck | 2009-02-11 |
| K051633 | CD-CHEX PLUS BC | Streck | 2005-08-16 |
| K993126 | CD-CHEX CD 34 | Streck Laboratories, Inc. | 1999-11-26 |
| K960894 | CD-CHEX + RBC | Streck Laboratories, Inc. | 1996-05-24 |
| K931825 | CD-CHEX CD4 LOW | Streck Laboratories, Inc. | 1994-06-06 |
| K920997 | CD-CHEX | Streck Laboratories, Inc. | 1992-05-31 |
| K894651 | COULTER POSITIVE CONTROL CELLS | Coulter Corp. | 1989-09-13 |
Legacy Summary#
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FDA Review#
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