510(k) K972812

Device: RAICHEM PREALBUMIN SPIA
Applicant: HEMAGEN DIAGNOSTICS, INC.
510(k) number: K972812
Product code: DDS
Decision: Substantially Equivalent (SESE)
Decision date: 1997-08-28
Date received: 1997-07-28
Regulation: 866.5060
Classification name: Prealbumin, Fitc, Antigen, Antiserum, Control
Medical specialty: Immunology
Review panel: Immunology
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: JOSEPH M CALIFANO
Address: 34-40 Bear Hill Rd. Waltham MA US 02154 02154

FDA Registration Numbers#

3003761012
1836161
2050010
2050012
9680746
2517506

Source Documents#

Other 510(k) Records For Product Code DDS #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K964781	IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT	Beckman Instruments, Inc.	1997-05-09
K934966	SPQ PAL CONTROL LEVEL II	Incstar Corp.	1994-01-11
K854811	ICS PAB PREALBUMIN REAGENT TEST KIT	Beckman Instruments, Inc.	1986-01-24

Legacy Summary#

summary

FDA Review#

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