The following data is part of a premarket notification filed by Atlantic Antibodies with the FDA for Spq Tm Test System Ii For Crp.
Device ID | K892526 |
510k Number | K892526 |
Device Name: | SPQ TM TEST SYSTEM II FOR CRP |
Classification | C-reactive Protein, Antigen, Antiserum, And 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 | DCK |
CFR Regulation Number | 866.5270 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-11 |
Decision Date | 1989-05-09 |