BIO-RAD CODA NEONATAL GALT ASSAY
FDA 510(k) clearance K993536 · decided 1999-11-04
Clearance details
- K-number
- K993536
- Device name
- BIO-RAD CODA NEONATAL GALT ASSAY
- Applicant
- Bio-Rad
- Decision
- Substantially Equivalent
- Date received
- 1999-10-19
- Decision date
- 1999-11-04
- Days to decision
- 16 days
- Clearance type
- Special
- Product code
- KQP
- Device class
- 2
- Regulation number
- 862.1315
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Hercules, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT (K102643) | Astoria-Pacific, Inc. | 2011-07-15 |
| NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D (K101392) | Astoria-Pacific, Inc. | 2011-02-04 |
| GSP NEONATALGALT KIT, MODEL 3303-001U (K100101) | Perkinelmer, Inc. | 2010-06-11 |
| MICROPLATE NEONATAL GALT ASSAY (K990827) | Bio-Rad | 1999-04-09 |
| URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) (K970277) | Astoria-Pacific, Inc. | 1997-12-11 |
| TOTAL GALACTOSE (K894011) | Alpkem Corp. | 1990-01-11 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S002) | Bio-Rad | 1996-03-01 |
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S001) | Bio-Rad | 1991-03-14 |
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032) | Bio-Rad | 1989-07-24 |