The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Hemoglobin Variants System On Newborn Hemoglobin System With Gdm And Hbreview Software.
| Device ID | K171664 |
| 510k Number | K171664 |
| Device Name: | Hemoglobin Variants System On Newborn Hemoglobin System With GDM And HbReview Software |
| Classification | Abnormal Hemoglobin Quantitation |
| Applicant | Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94547 |
| Contact | Sweta Patel |
| Correspondent | Sweta Patel Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive 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 | 2017-06-05 |
| Decision Date | 2017-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847817007187 | K171664 | 000 |
| 00847817007170 | K171664 | 000 |
| 00847817007156 | K171664 | 000 |
| 00847817007071 | K171664 | 000 |
| 00847817007064 | K171664 | 000 |
| 00847817007057 | K171664 | 000 |
| 00847817006791 | K171664 | 000 |
| 00847817007163 | K171664 | 000 |