ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K

Glucose-6-phosphate Dehydrogenase (erythrocytic), Quantitative

ASTORIA-PACIFIC,INC.

The following data is part of a premarket notification filed by Astoria-pacific,inc. with the FDA for Astoria-pacific Spotcheck G6pd Kit 50 Hr, Model 80-3000-13k.

Pre-market Notification Details

• Device ID: K990957
• 510k Number: K990957
• Device Name: ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K
• Classification: Glucose-6-phosphate Dehydrogenase (erythrocytic), Quantitative
• Applicant: ASTORIA-PACIFIC,INC. 14600 S.E. 82ND DR. P.O. BOX 830 Clackamas, OR 97015
• Contact: Raymond L Pavitt
• Correspondent: Raymond L Pavitt; ASTORIA-PACIFIC,INC. 14600 S.E. 82ND DR. P.O. BOX 830 Clackamas, OR 97015
• Product Code: JBL
• CFR Regulation Number: 864.7360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-03-22
• Decision Date: 1999-05-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00725609000038	K990957	000
00725609000021	K990957	000