The following data is part of a premarket notification filed by Atlantic Antibodies with the FDA for Spq(tm) Test System For Prealbumin.
| Device ID | K884297 |
| 510k Number | K884297 |
| Device Name: | SPQ(TM) TEST SYSTEM FOR PREALBUMIN |
| Classification | Prealbumin, Antigen, Antiserum, Control |
| Applicant | ATLANTIC ANTIBODIES 10 NONESUCH RD. P.O. BOX 60 Scarborough, ME 04074 |
| Contact | Thomas Snyder |
| Correspondent | Thomas Snyder 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 |