STC Auto-Lyte Urinary Glucose Assay
FDA 510(k) K962435 · OraSure Technologies, Inc.
510(k) numberK962435
Submission
- Device name
- STC Auto-Lyte Urinary Glucose Assay
- Applicant
- OraSure Technologies, Inc.
Bethlehem, PA, US - Received
- June 24, 1996
- Decision date
- December 26, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CFR – Hexokinase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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| K123018 | Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode…CFR · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 04/23/2013SE |
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Questions and answers
When was STC Auto-Lyte Urinary Glucose Assay cleared by the FDA?
STC Auto-Lyte Urinary Glucose Assay (K962435) received a 510(k) decision of Substantially Equivalent on December 26, 1996, 185 days after the submission was received.
What is the product code of K962435?
The FDA product code is CFR – Hexokinase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.