The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Hemoglobin Capillary Collection System (hccs), 1 Test, Hemoglobin Capillary Collection System (hccs), 5 Tests, Hemoglobi.
| Device ID | K090737 |
| 510k Number | K090737 |
| Device Name: | HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | BIO-RAD LABORATORIES, INC. 4000 ALFRED NOBEL DR Hercules, CA 94547 |
| Contact | Jolene Bartilson |
| Correspondent | Jolene Bartilson BIO-RAD LABORATORIES, INC. 4000 ALFRED NOBEL DR Hercules, CA 94547 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-20 |
| Decision Date | 2009-06-03 |
| Summary: | summary |