The following data is part of a premarket notification filed by Bio-rad Laboratories Inc., Clinical Systems Divisi with the FDA for Variant Nbs Sickle Cell Program Reagent Kit, Variant Nbs Newborn Screening System And Variant Nbs Workstation With.
| Device ID | K080911 |
| 510k Number | K080911 |
| Device Name: | VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH |
| Classification | Abnormal Hemoglobin Quantitation |
| Applicant | BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI 4000 ALFRED NOBEL DR. Hercules, CA 94547 |
| Contact | J.b Bartilson |
| Correspondent | J.b Bartilson BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI 4000 ALFRED NOBEL DR. Hercules, CA 94547 |
| Product Code | GKA |
| CFR Regulation Number | 864.7415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-02 |
| Decision Date | 2008-05-02 |
| Summary: | summary |