Abbott Architech Glycated Hemoglobin Mastercheck
FDA 510(k) K992710 · Abbott Laboratories
510(k) numberK992710
Submission
- Device name
- Abbott Architech Glycated Hemoglobin Mastercheck
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- August 11, 1999
- Decision date
- November 24, 1999
- 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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Questions and answers
When was Abbott Architech Glycated Hemoglobin Mastercheck cleared by the FDA?
Abbott Architech Glycated Hemoglobin Mastercheck (K992710) received a 510(k) decision of Substantially Equivalent on November 24, 1999, 105 days after the submission was received.
What is the product code of K992710?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.