A firm is preparing a 510(k) for a microhematocrit analyzer. To whom should the submission be addressed?

In the context of preparing a 510(k) submission for a microhematocrit analyzer, the correct address for the submission is to CDRH (Center for Devices and Radiological Health). The CDRH is the FDA branch responsible for the regulation of medical devices, which includes equipment like microhematocrit analyzers.

While CBER (Center for Biologics Evaluation and Research), CDER (Center for Drug Evaluation and Research), and CVM (Center for Veterinary Medicine) are all important FDA components, their focus does not include medical devices such as the analyzer mentioned in the question. CBER oversees biological products, CDER focuses primarily on drug products, and CVM regulates animal drugs and devices. Therefore, addressing the submission to CDRH is essential for proper review and approval under the 510(k) premarket notification process, which is applicable to devices to demonstrate that they are safe and effective by showing substantial equivalence to a legally marketed device.