The following data is part of a premarket notification filed by Kent Laboratories, Inc. with the FDA for Antiserum To Human Apolipoprotein A-i.
| Device ID | K850691 |
| 510k Number | K850691 |
| Device Name: | ANTISERUM TO HUMAN APOLIPOPROTEIN A-I |
| Classification | Apolipoproteins |
| Applicant | KENT LABORATORIES, INC. 23404 N.E. 8TH ST. Redmond, WA 98053 |
| Contact | Allan H Jorgensen |
| Correspondent | Allan H Jorgensen KENT LABORATORIES, INC. 23404 N.E. 8TH ST. Redmond, WA 98053 |
| Product Code | MSJ |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-21 |
| Decision Date | 1985-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B1761500 | K850691 | 000 |