The following data is part of a premarket notification filed by Osborn Group, Inc. with the FDA for Appraise-cardio Sample Collection Kit.
| Device ID | K993787 |
| 510k Number | K993787 |
| Device Name: | APPRAISE-CARDIO SAMPLE COLLECTION KIT |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | OSBORN GROUP, INC. 14901 WEST 117TH ST. Olathe, KS 66062 |
| Contact | Gilbert P Bourk Iii |
| Correspondent | Gilbert P Bourk Iii OSBORN GROUP, INC. 14901 WEST 117TH ST. Olathe, KS 66062 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-09 |
| Decision Date | 2000-04-14 |
| Summary: | summary |