FDA 510(k) Application Details - K990641

Device Classification Name	Stain, Fetal Hemoglobin   More FDA Info for this Device
510(K) Number	K990641
Device Name	Stain, Fetal Hemoglobin
Applicant	CALTAG LABORATORIES, INC. 605 DILWORTH RD. DOWNINGTOWN, PA 19335 US Other 510(k) Applications for this Company
Contact	DAVID C BISHOP Other 510(k) Applications for this Contact
Regulation Number	864.7455   More FDA Info for this Regulation Number
Classification Product Code	GHQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/26/1999
Decision Date	09/17/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review