Neonatal Chemistry System, Galactose Test Kit
FDA 510(k) K950481 · Isolab, Inc.
510(k) numberK950481
Submission
- Device name
- Neonatal Chemistry System, Galactose Test Kit
- Applicant
- Isolab, Inc.
Akron, OH, US - Received
- February 3, 1995
- Decision date
- February 1, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
| K951329 | Immuchem Gal-Mw EaJIA · Traditional | Icn Pharmaceuticals, Inc. | 11/09/1995SE |
More from Icn Pharmaceuticals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K951014 | Isolab's T4 Test KitKLI · Traditional | 10/18/1996SE |
| K943547 | Phenylalanine Test KitJNB · Traditional | 01/26/1996SE |
| K950803 | Isolab's GALACTOSE-1-PHOSPHATE Uridyl Tranferase Test Kits 800, 4000 SampleJJT · Traditional | 09/21/1995SE |
| K950415 | Fluoroscan NeonatalKHO · Traditional | 09/05/1995SE |
| K942276 | Quik-Sep Quantitative Hemoglobin S AssayGIQ · Traditional | 01/20/1995SE |
| K942222 | Quik-Sep Quantitive Hemoglobin S ControlsJCM · Traditional | 01/20/1995SE |
| K944185 | IsoscanJQT · Traditional | 11/17/1994SE |
| K934013 | Resolve Systems Alkaline Phosphatase Test KitCIN · Traditional | 04/26/1994SE |
| K923153 | Hemocard, Hemoglobin C AssayMLL · Traditional | 01/27/1994SE |
| K931234 | Hemocard Control Hb-Aa, Ae, Faa, FaeJCM · Traditional | 05/11/1993SE |
Questions and answers
When was Neonatal Chemistry System, Galactose Test Kit cleared by the FDA?
Neonatal Chemistry System, Galactose Test Kit (K950481) received a 510(k) decision of Substantially Equivalent on February 1, 1996, 363 days after the submission was received.
What is the product code of K950481?
The FDA product code is JIA – Enzymatic Methods, Galactose, a Class I (low risk) device regulated under 21 CFR 862.1310.