The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for A.qc Hct Level 1 And 2.
| Device ID | K893562 |
| 510k Number | K893562 |
| Device Name: | A.QC HCT LEVEL 1 AND 2 |
| Classification | Control, Hematocrit |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 2675 LONG LAKE RD. Roseville, MN 55113 |
| Contact | Peter J Cordon |
| Correspondent | Peter J Cordon JOHNSON & JOHNSON PROFESSIONALS, INC. 2675 LONG LAKE RD. Roseville, MN 55113 |
| Product Code | GLK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-09 |
| Decision Date | 1989-07-14 |