510(k) K990957

Device: ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K
Applicant: ASTORIA-PACIFIC,INC.
510(k) number: K990957
Product code: JBL
Decision: Substantially Equivalent (SESE)
Decision date: 1999-05-11
Date received: 1999-03-22
Regulation: 864.7360
Classification name: Glucose-6-phosphate Dehydrogenase (erythrocytic), Quantitative
Medical specialty: Hematology
Review panel: Hematology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: RAYMOND L PAVITT
Address: 14600 SE 82nd Dr. P.O. Box 830 Clackamas OR US 97015 97015

FDA Registration Numbers#

3050015
9681576
3011240982

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00725609000038	SPOTCHECK	ASTORIA-PACIFIC, INC.	2016-10-14
00725609000021	SPOTCHECK	ASTORIA-PACIFIC, INC.	2016-10-14

Other 510(k) Records For Product Code JBL #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K790211	DEHYDROGENOSE, GLUCOSE PHOSPHATE	Sigma Chemical Co.	1979-03-15

Legacy Summary#

summary

FDA Review#

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