Model 644 Sweat Diluent
FDA 510(k) K935228 · Ciba Corning Diagnostics Corp.
510(k) numberK935228
Submission
- Device name
- Model 644 Sweat Diluent
- Applicant
- Ciba Corning Diagnostics Corp.
Medfield, MA, US - Received
- November 1, 1993
- Decision date
- August 1, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CGZ – Electrode, Ion-Specific, Chloride
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1170
- Specialty
- Clinical Chemistry
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| K962041 | Acs LH2 ImmunoassayCEP · Traditional | 06/21/1996SE |
| K961510 | Acs FRT4 ImmunoassayJJX · Traditional | 06/17/1996SE |
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Questions and answers
When was Model 644 Sweat Diluent cleared by the FDA?
Model 644 Sweat Diluent (K935228) received a 510(k) decision of Substantially Equivalent on August 1, 1994, 273 days after the submission was received.
What is the product code of K935228?
The FDA product code is CGZ – Electrode, Ion-Specific, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.