The following data is part of a premarket notification filed by Precision Biologic with the FDA for Reference Check, Catalog Number-rcn-10.
| Device ID | K013708 |
| 510k Number | K013708 |
| Device Name: | REFERENCE CHECK, CATALOG NUMBER-RCN-10 |
| Classification | Plasma, Control, Normal |
| Applicant | PRECISION BIOLOGIC 900 WINDMILL RD., SUITE 100 Dartmouth, N.s., CA B3b 1p7 |
| Contact | Stephen L Duff |
| Correspondent | Stephen L Duff PRECISION BIOLOGIC 900 WINDMILL RD., SUITE 100 Dartmouth, N.s., CA B3b 1p7 |
| Product Code | GIZ |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-08 |
| Decision Date | 2001-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843876000060 | K013708 | 000 |
| 00843876000053 | K013708 | 000 |