Spotcheck Neonatal Galt Microplate Reagent Kit
FDA 510(k) K102643 · Astoria-Pacific, Inc.
510(k) numberK102643
Submission
- Device name
- Spotcheck Neonatal Galt Microplate Reagent Kit
- Applicant
- Astoria-Pacific, Inc.
Clackamas, OR, US - Received
- September 14, 2010
- Decision date
- July 15, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KQP – Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1315
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K101392 | Neopac Software, 3007 Digital Photometer/Fluorometer Model Na, 307 and 350DKQP · Traditional | Astoria-Pacific, Inc. | 02/04/2011SE |
| K100101 | GSP Neonatalgalt Kit, Model 3303-001UKQP · Traditional | Perkinelmer, Inc. | 06/11/2010SE |
| K993536 | Bio-Rad Coda Neonatal Galt AssayKQP · Special | Bio-Rad | 11/04/1999SE |
| K990827 | Microplate Neonatal Galt AssayKQP · Special | Bio-Rad | 04/09/1999SE |
| K970277 | Uridyltransferase Kit, 50 Hour (80-4000-13K)KQP · Traditional | Astoria-Pacific, Inc. | 12/11/1997SE |
| K894011 | Total GalactoseKQP · Traditional | Alpkem Corp. | 01/11/1990SE |
More from Alpkem Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K121101 | Spotcheck Neonatal Total Galactose Microplate Reagent KitJIA · Traditional | 06/20/2013SE |
| 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 Galt Microplate Reagent Kit cleared by the FDA?
Spotcheck Neonatal Galt Microplate Reagent Kit (K102643) received a 510(k) decision of Substantially Equivalent on July 15, 2011, 304 days after the submission was received.
What is the product code of K102643?
The FDA product code is KQP – Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase, a Class II (moderate risk) device regulated under 21 CFR 862.1315.