The following data is part of a premarket notification filed by Atlantic Antibodies with the FDA for Spq(tm) Test System For Microalbumin.
Device ID | K884298 |
510k Number | K884298 |
Device Name: | SPQ(TM) TEST SYSTEM FOR MICROALBUMIN |
Classification | Prealbumin, Antigen, Antiserum, Control |
Applicant | ATLANTIC ANTIBODIES 10 NONESUCH RD. P.O. BOX 60 Scarborough, ME 04074 |
Contact | Glenn Irish |
Correspondent | Glenn Irish ATLANTIC ANTIBODIES 10 NONESUCH RD. P.O. BOX 60 Scarborough, ME 04074 |
Product Code | JZJ |
CFR Regulation Number | 866.5060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-10-12 |
Decision Date | 1988-11-02 |