SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT
FDA 510(k) clearance K102643 · decided 2011-07-15
Clearance details
- K-number
- K102643
- Device name
- SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT
- Applicant
- Astoria-Pacific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-09-14
- Decision date
- 2011-07-15
- Days to decision
- 304 days
- Clearance type
- Traditional
- Product code
- KQP
- Device class
- 2
- Regulation number
- 862.1315
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Clackamas, OR, 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 |
|---|---|---|
| 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 |
| BIO-RAD CODA NEONATAL GALT ASSAY (K993536) | Bio-Rad | 1999-11-04 |
| 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.