GSP Neonatal Total Galactose kit
FDA 510(k) clearance K190335 · decided 2019-11-06
Clearance details
- K-number
- K190335
- Device name
- GSP Neonatal Total Galactose kit
- Applicant
- Perkinelmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-02-14
- Decision date
- 2019-11-06
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- JIA
- Device class
- 1
- Regulation number
- 862.1310
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Waltham, MA, 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 |
|---|---|---|
| GSP NEONATAL TOTAL GALACTOSE KIT (K133652) | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2014-04-28 |
| SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT (K121101) | Astoria-Pacific, Inc. | 2013-06-20 |
| NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B (K071649) | Wallac OY | 2008-08-07 |
| QUANTASE TOTAL GALACTOSE SCREENING ASSAY (K990644) | Quantase , Ltd. | 1999-06-21 |
| QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT (K990654) | Quantase , Ltd. | 1999-06-21 |
| ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL (K991498) | Neometrics, Inc. | 1999-06-16 |
| NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT (K950481) | Isolab, Inc. | 1996-02-01 |
| IMMUCHEM GAL-MW EA (K951329) | Icn Pharmaceuticals, Inc. | 1995-11-09 |
Recalls involving this device
No recalls on record reference this clearance.