Oxyhemoglobin Control for Co-Oximetry
FDA 510(k) K980178 · Bionostics, Inc.
510(k) numberK980178
Submission
- Device name
- Oxyhemoglobin Control for Co-Oximetry
- Applicant
- Bionostics, Inc.
Acton, MA, US - Received
- January 20, 1998
- Decision date
- February 12, 1998
- 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 Oxyhemoglobin Control for Co-Oximetry cleared by the FDA?
Oxyhemoglobin Control for Co-Oximetry (K980178) received a 510(k) decision of Substantially Equivalent on February 12, 1998, 23 days after the submission was received.
What is the product code of K980178?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.