GSP Neonatal Total Galactose kit
FDA 510(k) K190335 · Perkinelmer, Inc.
510(k) numberK190335
Submission
- Device name
- GSP Neonatal Total Galactose kit
- Applicant
- Perkinelmer, Inc.
Waltham, MA, US - Received
- February 14, 2019
- Decision date
- November 6, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIA – Enzymatic Methods, Galactose
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1310
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JIA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K133652 | GSP Neonatal Total Galactose KitJIA · Traditional | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 04/28/2014SE |
| K121101 | Spotcheck Neonatal Total Galactose Microplate Reagent KitJIA · Traditional | Astoria-Pacific, Inc. | 06/20/2013SE |
| K071649 | Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 and 3029-110BJIA · Traditional | Wallac OY | 08/07/2008SE |
| K990654 | Quantase Total Galactose Screening Assay 500 Test KitJIA · Traditional | Quantase , Ltd. | 06/21/1999SE |
| K990644 | Quantase Total Galactose Screening AssayJIA · Traditional | Quantase , Ltd. | 06/21/1999SE |
| K991498 | Accuwell Total Galactose, Model 6010-EGALJIA · Traditional | Neometrics, Inc. | 06/16/1999SE |
| K950481 | Neonatal Chemistry System, Galactose Test KitJIA · Traditional | Isolab, Inc. | 02/01/1996SE |
| K951329 | Immuchem Gal-Mw EaJIA · Traditional | Icn Pharmaceuticals, Inc. | 11/09/1995SE |
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Questions and answers
When was GSP Neonatal Total Galactose kit cleared by the FDA?
GSP Neonatal Total Galactose kit (K190335) received a 510(k) decision of Substantially Equivalent on November 6, 2019, 265 days after the submission was received.
What is the product code of K190335?
The FDA product code is JIA – Enzymatic Methods, Galactose, a Class I (low risk) device regulated under 21 CFR 862.1310.