The following data is part of a premarket notification filed by Atlantic Antibodies with the FDA for Modified Spq(tm) Test System For Apolipoprotein B.
| Device ID | K881898 |
| 510k Number | K881898 |
| Device Name: | MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B |
| Classification | Apolipoproteins |
| 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 | MSJ |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-28 |
| Decision Date | 1988-06-14 |