Immuchem Gal-Mw Ea
FDA 510(k) K951329 · Icn Pharmaceuticals, Inc.
510(k) numberK951329
Submission
- Device name
- Immuchem Gal-Mw Ea
- Applicant
- Icn Pharmaceuticals, Inc.
Costa Mesa, CA, US - Received
- March 23, 1995
- Decision date
- November 9, 1995
- 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 |
| K950481 | Neonatal Chemistry System, Galactose Test KitJIA · Traditional | Isolab, Inc. | 02/01/1996SE |
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| K914081 | Ican Cotton Rayon BallsFRL · Traditional | 10/09/1991SE |
| K913446 | Ican Needle CountersMMK · Traditional | 09/13/1991SE |
| K904398 | Water Column Relief ValveCAF · Traditional | 07/09/1991SE |
| K770458 | Bilirubin Procedure, Tekpoint Tot & Dir.CIG · Traditional | 05/10/1977SE |
| K770457 | Cholesterol Procedure, Tekpoint TotalCGO · Traditional | 05/03/1977SE |
Questions and answers
When was Immuchem Gal-Mw Ea cleared by the FDA?
Immuchem Gal-Mw Ea (K951329) received a 510(k) decision of Substantially Equivalent on November 9, 1995, 231 days after the submission was received.
What is the product code of K951329?
The FDA product code is JIA – Enzymatic Methods, Galactose, a Class I (low risk) device regulated under 21 CFR 862.1310.