Sugar Chex One
FDA 510(k) K001443 · Streck Laboratories, Inc.
510(k) numberK001443
Submission
- Device name
- Sugar Chex One
- Applicant
- Streck Laboratories, Inc.
Omaha, NE, US - Received
- May 8, 2000
- Decision date
- June 29, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K011410 | Para 5XJPK · Traditional | 06/26/2001SE |
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Questions and answers
When was Sugar Chex One cleared by the FDA?
Sugar Chex One (K001443) received a 510(k) decision of Substantially Equivalent on June 29, 2000, 52 days after the submission was received.
What is the product code of K001443?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.