Stains, Hematology
This device consists of hematology stains, which are chemical reagents used to stain blood cell components on microscope slides for morphological examination and differential blood cell analysis in clinical and research laboratories. It is classified as FDA Class 1, the lowest risk category, subject to general controls. The product code is KQC, regulated under 21 CFR 864.1850 within the Hematology specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
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Basic Information
- Product Code
- KQC
- Device Class
- FDA class 1
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K882873 | FIELDTEX HEMATOXYLIN | Jul 28, 1988 | Substantially Equivalent | Anatech, Ltd. |
| K852843 | GENERAL DIAGNOSTICS COAG-A-MATE XC | Aug 13, 1985 | Substantially Equivalent | Warner-Lambert Co. |
| K843619 | RETIC-SET | Oct 30, 1984 | Substantially Equivalent | R&D Systems, Inc. |
| K841848 | RETIC-SET | May 31, 1984 | Substantially Equivalent | R&D Systems, Inc. |
| K792550 | PONCEAU S STAIN SET | Jan 16, 1980 | Substantially Equivalent | Electrophoresis Corp. of America |
| K792496 | VOLU-SOL NMB RETICULOCYTE STAIN | Dec 31, 1979 | Substantially Equivalent | Volu Sol Medical Industries |
| K791007 | STAT DIFF STAIN | Aug 03, 1979 | Substantially Equivalent | Bioscientific |
| K760487 | HEMASTAIN PHOSPHATE BUFFER | Aug 30, 1976 | Substantially Equivalent | Geometric Data, Div. Smithkline Corp. |
| K760485 | HEMASTAIN FIXATIVE | Aug 30, 1976 | Substantially Equivalent | Geometric Data, Div. Smithkline Corp. |
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.