Spotcheck Neonatal Total Galactose Microplate Reagent Kit
FDA 510(k) K121101 · Astoria-Pacific, Inc.
510(k) numberK121101
Submission
- Device name
- Spotcheck Neonatal Total Galactose Microplate Reagent Kit
- Applicant
- Astoria-Pacific, Inc.
Clackamas, OR, US - Received
- April 11, 2012
- Decision date
- June 20, 2013
- 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 |
|---|---|---|---|
| K190335 | GSP Neonatal Total Galactose kitJIA · Traditional | Perkinelmer, Inc. | 11/06/2019SE |
| K133652 | GSP Neonatal Total Galactose KitJIA · Traditional | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 04/28/2014SE |
| 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 |
More from Icn Pharmaceuticals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K102643 | Spotcheck Neonatal Galt Microplate Reagent KitKQP · Traditional | 07/15/2011SE |
| K101392 | Neopac Software, 3007 Digital Photometer/Fluorometer Model Na, 307 and 350DKQP · Traditional | 02/04/2011SE |
| K090940 | Spotcheck Blood Spot Control, AssayedJJT · Traditional | 12/14/2009SE |
| K080294 | Astoria-Pacific Spotcheck Biotinidase Microplate Reagent KitNAK · Traditional | 11/04/2008SE |
| K010844 | Astoria-Pacific Spotcheck Biotinidase Kit, 50 Hour, Part No. 80-8000-13KNAK · Traditional | 09/21/2001SE |
| K990957 | Astoria-Pacific Spotcheck G6PD Kit 50 HR, Model 80-3000-13KJBL · Traditional | 05/11/1999SE |
| K970093 | Tyrosine 50-HOUR Reagent KitCDR · Traditional | 03/19/1998SE |
| K970277 | Uridyltransferase Kit, 50 Hour (80-4000-13K)KQP · Traditional | 12/11/1997SE |
Questions and answers
When was Spotcheck Neonatal Total Galactose Microplate Reagent Kit cleared by the FDA?
Spotcheck Neonatal Total Galactose Microplate Reagent Kit (K121101) received a 510(k) decision of Substantially Equivalent on June 20, 2013, 435 days after the submission was received.
What is the product code of K121101?
The FDA product code is JIA – Enzymatic Methods, Galactose, a Class I (low risk) device regulated under 21 CFR 862.1310.