510(k) K133652
- Device
- GSP NEONATAL TOTAL GALACTOSE KIT
- Applicant
- WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC.
- 510(k) number
- K133652
- Product code
- JIA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-04-28
- Date received
- 2013-11-27
- Regulation
- 862.1310
- Classification name
- Enzymatic Methods, Galactose
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEANETTE SCHIER-PUGSLEY
- Address
- 940 Winter St. Waltham MA US 02451 02451
FDA Registration Numbers#
- 3050015
- 8043909
Source Documents#
Other 510(k) Records For Product Code JIA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K190335 | GSP Neonatal Total Galactose kit | Perkinelmer, Inc. | 2019-11-06 |
| K121101 | SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT | Astoria-Pacific, Inc. | 2013-06-20 |
| K071649 | NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B | Wallac OY | 2008-08-07 |
| K990644 | QUANTASE TOTAL GALACTOSE SCREENING ASSAY | Quantase , Ltd. | 1999-06-21 |
| K990654 | QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT | Quantase , Ltd. | 1999-06-21 |
| K991498 | ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL | Neometrics, Inc. | 1999-06-16 |
| K950481 | NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT | Isolab, Inc. | 1996-02-01 |
| K951329 | IMMUCHEM GAL-MW EA | Icn Pharmaceuticals, Inc. | 1995-11-09 |
Legacy Summary#
summary
FDA Review#
Decision Summary