The following data is part of a premarket notification filed by Scientific Sales Intl., Inc. with the FDA for Iap Plate Test.
| Device ID | K861336 |
| 510k Number | K861336 |
| Device Name: | IAP PLATE TEST |
| Classification | Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control |
| Applicant | SCIENTIFIC SALES INTL., INC. P.O. BOX 1538 Kalamazoo, MI 49005 |
| Contact | Nicolas Schmelzer |
| Correspondent | Nicolas Schmelzer SCIENTIFIC SALES INTL., INC. P.O. BOX 1538 Kalamazoo, MI 49005 |
| Product Code | LKL |
| CFR Regulation Number | 866.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-09 |
| Decision Date | 1986-04-25 |