ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K

System, Test, Biotinidase

ASTORIA-PACIFIC,INC.

The following data is part of a premarket notification filed by Astoria-pacific,inc. with the FDA for Astoria-pacific Spotcheck Biotinidase Kit, 50 Hour, Part No. 80-8000-13k.

Pre-market Notification Details

• Device ID: K010844
• 510k Number: K010844
• Device Name: ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K
• Classification: System, Test, Biotinidase
• Applicant: ASTORIA-PACIFIC,INC. 15130 S.E. 82ND DR. P.O. BOX 830 Clakamas, OR 97015 -0830
• Contact: Raymond L Pavitt
• Correspondent: Raymond L Pavitt; ASTORIA-PACIFIC,INC. 15130 S.E. 82ND DR. P.O. BOX 830 Clakamas, OR 97015 -0830
• Product Code: NAK
• CFR Regulation Number: 862.1118 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-03-21
• Decision Date: 2001-09-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00725609000250	K010844	000
00725609000243	K010844	000
00725609000236	K010844	000
00725609000229	K010844	000
00725609000083	K010844	000
00725609000076	K010844	000