Micro-Hematocrit Centrifuge 335/336
by Fisher Scientific Co., LLC 510(k)
Active
510(k) K823558
Overview
The Micro-Hematocrit Centrifuge 335/336 is a Hematocrit Measuring Device, designed to separate blood components by centrifugal force for hematocrit determination. It operates by spinning microhematocrit capillary tubes to sediment red blood cells, enabling precise measurement of packed cell volume. This device is classified under the Hematology specialty and falls within the Class II regulatory category, requiring premarket notification (510(k)) clearance in the United States. Its primary function aligns with clinical hematology assessments, particularly in laboratory settings.
The Micro-Hematocrit Centrifuge 335/336 is intended for use in clinical laboratories and is supplied as a reusable instrument. It is not described as sterile or single-use in the regulatory data. The device is MRI-unsafe due to its metallic components and rotational mechanics, requiring exclusion from MRI environments. No specific storage conditions are detailed, but standard laboratory practices for mechanical centrifuges apply. The device holds FDA 510(k) clearance (K823558) under the Hematology (HE) Advisory Committee, with a Substantially Equivalent determination, and is categorized under the JPI product code.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823558 | Date21 Jan 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JPI
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.6400
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Fisher Scientific Co., LLC
Questions
What is the Micro-Hematocrit Centrifuge 335/336 used for?
This device is designed for clinical hematology assessments, specifically to determine hematocrit levels by spinning microhematocrit capillary tubes. The centrifugal force separates red blood cells, allowing precise measurement of packed cell volume—a key metric in evaluating blood health, anemia, or hydration status in laboratory settings.
Is the Micro-Hematocrit Centrifuge 335/336 single-use or reusable?
The device is supplied as a reusable instrument. It is not intended for single-use or sterile applications, so it requires proper cleaning and maintenance between uses in a clinical lab environment.
What regulatory clearance does the Micro-Hematocrit Centrifuge 335/336 hold?
The device holds FDA 510(k) clearance under the Hematology (HE) Advisory Committee, with a Substantially Equivalent determination (K823558). It falls under Class II regulatory classification, requiring premarket notification before commercial distribution in the U.S.
Can the Micro-Hematocrit Centrifuge 335/336 be used in an MRI environment?
No, the device is MRI-unsafe due to its metallic components and rotational mechanics. It must be excluded from MRI environments to avoid interference or safety risks.
What storage conditions should be followed for the Micro-Hematocrit Centrifuge 335/336?
While specific storage conditions aren’t detailed, standard laboratory practices for mechanical centrifuges apply. Store in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of vibration. Ensure the device is properly secured and protected from physical damage.