Dye Check Strips 545-630
FDA 510(k) K943729 · Awareness Technology, Inc.
510(k) numberK943729
Submission
- Device name
- Dye Check Strips 545-630
- Applicant
- Awareness Technology, Inc.
Palm City, FL, US - Received
- August 2, 1994
- Decision date
- December 29, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K900224 | Stat FAX(TM)-2100JJQ · Traditional | 03/01/1990SE |
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Questions and answers
When was Dye Check Strips 545-630 cleared by the FDA?
Dye Check Strips 545-630 (K943729) received a 510(k) decision of Substantially Equivalent on December 29, 1994, 149 days after the submission was received.
What is the product code of K943729?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.