Careside Globulin
FDA 510(k) K980055 · Exigent Diagnostics, Inc.
510(k) numberK980055
Submission
- Device name
- Careside Globulin
- Applicant
- Exigent Diagnostics, Inc.
Culver City, CA, US - Received
- January 6, 1998
- Decision date
- January 28, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JGE – Turbidimetric Method, Globulin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1330
- Specialty
- Clinical Chemistry
More from Exigent Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K982118 | Careside AnalyzerCHH · Traditional | 07/24/1998SE |
| K981899 | Careside Hdl-CholesterolLBS · Traditional | 07/14/1998SE |
| K981183 | Careside GlucoseCGA · Traditional | 05/07/1998SE |
| K980043 | Careside CreatinineJFY · Traditional | 03/30/1998SE |
| K980056 | Careside AnalyzerJJF · Traditional | 03/06/1998SE |
| K980057 | Careside BunCDQ · Traditional | 02/05/1998SE |
| K980042 | Careside Total ProteinCEK · Traditional | 02/04/1998SE |
| K980041 | Careside AlbuminCIX · Traditional | 02/04/1998SE |
Questions and answers
When was Careside Globulin cleared by the FDA?
Careside Globulin (K980055) received a 510(k) decision of Substantially Equivalent on January 28, 1998, 22 days after the submission was received.
What is the product code of K980055?
The FDA product code is JGE – Turbidimetric Method, Globulin, a Class I (low risk) device regulated under 21 CFR 862.1330.