01-18343. Hematology and Pathology Devices; Reclassification of Automated Differential Cell Counters; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Proposed rule; correction.

SUMMARY:

The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of May 9, 2001 (66 FR 23634). The document proposes to reclassify from class III (premarket approval) to class II (special controls) the automated differential cell counter (ADCC). The document published inadvertently with the incorrect docket number. This document corrects that error.

FOR FURTHER INFORMATION CONTACT:

Joyce Strong, Office of Policy, Planning, and Legislation (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010.

SUPPLEMENTARY INFORMATION:

In FR Doc. 01-11580, appearing in the Federal Register of Wednesday, May 9, 2001, the following correction is made: On page 23634, in the second column, “[Docket No. 95P-0351]” is corrected to read “[Docket No. 95P-0315].”

Dated: July 17, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.