Sweat Controls for Cystic Fibrosis Testing
FDA 510(k) K943925 · Quantimetrix Corp.
510(k) numberK943925
Submission
- Device name
- Sweat Controls for Cystic Fibrosis Testing
- Applicant
- Quantimetrix Corp.
Hawthorne, CA, US - Received
- August 12, 1994
- Decision date
- October 4, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJR – Electrolyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K990971 | Easylyte Quality Control Kit, Models 2814, 2815, 2816JJR · Traditional | Medica Corp. | 04/27/1999SE |
| K960592 | Electrolyte StandardsJJR · Traditional | Phoenix Diagnostics, Inc. | 05/13/1996SE |
| K955630 | RNA Medical Hemat ControlJJR · Traditional | Bionostics, Inc. | 03/01/1996SE |
| K951435 | Aalto Scientific Sweat Chloride Reference MaterialJJR · Traditional | Aalto Scientific, Ltd. | 05/02/1995SE |
| K934641 | I-Stat Control Levels 1,2,3JJR · Traditional | I-Stat Corp. | 12/09/1993SE |
| K912513 | Electrolyte ControlJJR · Traditional | Verichem Laboratories, Inc. | 07/19/1991SE |
| K902266 | Electrolyte Controls (Assayed and Unassayed)JJR · Traditional | Phoenix Diagnostics, Inc. | 06/06/1990SE |
| K894576 | Ciba Corning Certain LyteJJR · Traditional | Ciba Corning Diagnostics Corp. | 10/30/1989SE |
| K895582 | Qclyte Protein-Based Ise ControlJJR · Traditional | Baxter Healthcare Corp | 10/04/1989SE |
| K881773 | Document(Tm) Direct Ise Linearity Test SetJJR · Traditional | Casco Standards | 06/10/1988SE |
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Questions and answers
When was Sweat Controls for Cystic Fibrosis Testing cleared by the FDA?
Sweat Controls for Cystic Fibrosis Testing (K943925) received a 510(k) decision of Substantially Equivalent on October 4, 1994, 53 days after the submission was received.
What is the product code of K943925?
The FDA product code is JJR – Electrolyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.