Ise Calibrators for Corning 600 Series Analyzers
FDA 510(k) K930796 · Alko Diagnostic Corp.
510(k) numberK930796
Submission
- Device name
- Ise Calibrators for Corning 600 Series Analyzers
- Applicant
- Alko Diagnostic Corp.
Holliston, MA, US - Received
- February 16, 1993
- Decision date
- January 13, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JZX – Equipment, Rocket Immunoelectrophoresis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.4830
- Specialty
- Immunology
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| K955154 | Cal 1 & Cal 2 Solution, Flush Solution KitJIX · Traditional | 12/11/1995SE |
| K951071 | Alko Slope THB Solution for Corning 280, 288 and 2500 AnalyzersKRZ · Traditional | 07/24/1995SE |
| K950902 | Alko Tonometered Saline ControlJJS · Traditional | 03/30/1995SE |
Questions and answers
When was Ise Calibrators for Corning 600 Series Analyzers cleared by the FDA?
Ise Calibrators for Corning 600 Series Analyzers (K930796) received a 510(k) decision of Substantially Equivalent on January 13, 1994, 331 days after the submission was received.
What is the product code of K930796?
The FDA product code is JZX – Equipment, Rocket Immunoelectrophoresis, a Class I (low risk) device regulated under 21 CFR 866.4830.