Control, White-Cell
Control, White-Cell (product code GGL) is a quality control material used to verify the accuracy and precision of automated or manual white blood cell counting methods in clinical hematology laboratories. This device is classified as FDA Class 2, indicating moderate risk, and does not require premarket notification under the current classification. Regulated under 21 CFR 864.8625 in the Hematology specialty (HE), this device carries no flags for implantation, life support, GMP exemption, or third-party review.
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Basic Information
- Product Code
- GGL
- Device Class
- FDA class 2
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K083926 | CD4 COUNT | Feb 11, 2009 | Substantially Equivalent | Streck |
| K051633 | CD-CHEX PLUS BC | Aug 16, 2005 | Substantially Equivalent | Streck |
| K993126 | CD-CHEX CD 34 | Nov 26, 1999 | Substantially Equivalent | Streck Laboratories, Inc. |
| K960894 | CD-CHEX + RBC | May 24, 1996 | Substantially Equivalent | Streck Laboratories, Inc. |
| K931825 | CD-CHEX CD4 LOW | Jun 06, 1994 | Substantially Equivalent | Streck Laboratories, Inc. |
| K920997 | CD-CHEX | May 31, 1992 | Substantially Equivalent | Streck Laboratories, Inc. |
| K894651 | COULTER POSITIVE CONTROL CELLS | Sep 13, 1989 | Substantially Equivalent | Coulter Corp. |
| K891175 | EDL ABNORMAL COAGULATION CONTROL | Apr 10, 1989 | Substantially Equivalent | Elite Diagnostic , Ltd. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.