The following data is part of a premarket notification filed by Bio-rad with the FDA for Tip & Membrane Assembly.
| Device ID | K921443 |
| 510k Number | K921443 |
| Device Name: | TIP & MEMBRANE ASSEMBLY |
| Classification | Tonometer, Ac-powered |
| Applicant | BIO-RAD 635 WEST COLORADO ST. Glendale, CA 91204 |
| Contact | Richard W Teasdale |
| Correspondent | Richard W Teasdale BIO-RAD 635 WEST COLORADO ST. Glendale, CA 91204 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-25 |
| Decision Date | 1993-06-22 |