Access Ostase QC
FDA 510(k) K994277 · Beckman Coulter, Inc.
510(k) numberK994277
Submission
- Device name
- Access Ostase QC
- Applicant
- Beckman Coulter, Inc.
San Diego, CA, US - Received
- December 20, 1999
- Decision date
- January 14, 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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| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…LTT · Traditional | 08/20/2025SE |
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Questions and answers
When was Access Ostase QC cleared by the FDA?
Access Ostase QC (K994277) received a 510(k) decision of Substantially Equivalent on January 14, 2000, 25 days after the submission was received.
What is the product code of K994277?
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.