FDA 510(k) Application Details - K921968

Device Classification Name	Agglutination Method, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K921968
Device Name	Agglutination Method, Human Chorionic Gonadotropin
Applicant	TECH-CO, INC. 911 VIA RODEO PLACENTIA, CA 92670 US Other 510(k) Applications for this Company
Contact	K. C CHEN Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	JHJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/27/1992
Decision Date	06/28/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review