Bio-Rad Coda Neonatal Galt Assay
FDA 510(k) K993536 · Bio-Rad
510(k) numberK993536
Submission
- Device name
- Bio-Rad Coda Neonatal Galt Assay
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- October 19, 1999
- Decision date
- November 4, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|---|
| K102643 | Spotcheck Neonatal Galt Microplate Reagent KitKQP · Traditional | Astoria-Pacific, Inc. | 07/15/2011SE |
| 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 |
| 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 |
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| K070361 | MrsaselectJSO · Traditional | 09/13/2007SE |
| K060641 | Platelia Aspergillus Eia, Model 62793NOM · Traditional | 06/02/2006SE |
Questions and answers
When was Bio-Rad Coda Neonatal Galt Assay cleared by the FDA?
Bio-Rad Coda Neonatal Galt Assay (K993536) received a 510(k) decision of Substantially Equivalent on November 4, 1999, 16 days after the submission was received.
What is the product code of K993536?
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.