Control, Red-Cell
Control, Red-Cell (product code GJR) is a quality control material used to assess the performance of automated or manual red blood cell counting and characterization methods in hematology laboratories, ensuring the reliability of CBC results. 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 special regulatory flags.
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Basic Information
- Product Code
- GJR
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K080016 | NRBC-CHEX FOR ADVIA | Feb 05, 2008 | Substantially Equivalent | Streck |
| K060083 | NRBC-CHEX FOR LH | Feb 09, 2006 | Substantially Equivalent | Streck |
| K000076 | CELL-CHEX | Mar 03, 2000 | Substantially Equivalent | Streck Laboratories, Inc. |
| K940430 | SEDRATROL | Feb 06, 1995 | Substantially Equivalent | Medical Specialties Intl., Inc. |
| K900484 | RET-CHECK | Mar 09, 1990 | Substantially Equivalent | Streck Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.