Platelet Counting, Manual
The Manual Platelet Counting device is a hematology laboratory tool used to enumerate platelets in blood samples using manual microscopic methods, supporting the diagnosis and monitoring of thrombocytopenia and other platelet disorders. It is classified as FDA Class 1 (lowest risk), requiring only general controls and no premarket submission. The product code is GLG, governed by regulation 21 CFR 864.6160 in the Hematology specialty.
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Basic Information
- Product Code
- GLG
- Device Class
- FDA class 1
- Regulation Number
- 864.6160
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K842921 | REES & ECKER DILUTION FLUID | Sep 07, 1984 | Substantially Equivalent | E K Ind., Inc. |
| K811084 | LABTRONIX PLATELET COUNTER(L/O/C.) | Jul 23, 1981 | Substantially Equivalent | Labtronix Corp. |
| K772105 | PLATELET KIT | Nov 30, 1977 | Substantially Equivalent | Streck Laboratories, Inc. |
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.