The following data is part of a premarket notification filed by Clinical Controls, Inc. with the FDA for Liquispex(tm) Liquid B2m Control Level 1 And 2.
| Device ID | K946048 |
| 510k Number | K946048 |
| Device Name: | LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2 |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| Applicant | CLINICAL CONTROLS, INC. 750 FARROLL RD. SUITE B Grover Beach, CA 93433 |
| Contact | James F Godfrey |
| Correspondent | James F Godfrey CLINICAL CONTROLS, INC. 750 FARROLL RD. SUITE B Grover Beach, CA 93433 |
| Product Code | JZG |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-12 |
| Decision Date | 1995-02-10 |