The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Cla 200 Chempro(r) Lipid Analyzer.
| Device ID | K892238 |
| 510k Number | K892238 |
| Device Name: | CLA 200 CHEMPRO(R) LIPID ANALYZER |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| 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 | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-04 |
| Decision Date | 1989-06-07 |