The following data is part of a premarket notification filed by Precision Biologic with the FDA for Cryocheck Weak Lupus Positive Control.
| Device ID | K032804 |
| 510k Number | K032804 |
| Device Name: | CRYOCHECK WEAK LUPUS POSITIVE CONTROL |
| Classification | Control, Plasma, Abnormal |
| Applicant | PRECISION BIOLOGIC 900 WINDMILL RD., SUITE 100 Dartmouth, N.s., CA B3b 1p7 |
| Contact | Stephen Duff |
| Correspondent | Stephen Duff PRECISION BIOLOGIC 900 WINDMILL RD., SUITE 100 Dartmouth, N.s., CA B3b 1p7 |
| Product Code | GGC |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-09 |
| Decision Date | 2003-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843876000176 | K032804 | 000 |
| 00843876000169 | K032804 | 000 |