Accuscan Microbead Standards
FDA 510(k) K902294 · Sigma Chemical Co.
510(k) numberK902294
Submission
- Device name
- Accuscan Microbead Standards
- Applicant
- Sigma Chemical Co.
St. Louis, MO, US - Received
- May 22, 1990
- Decision date
- July 3, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIW – Calibrator, Surrogate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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| K933691 | Sigma CO2 Alkaline Buffer ReagentJFL · Traditional | 12/17/1993SE |
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| K933692 | Sigma CO2 Acid ReagentJFL · Traditional | 12/09/1993SE |
| K933695 | Sigma Electrolyte BufferJFL · Traditional | 10/22/1993SE |
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Questions and answers
When was Accuscan Microbead Standards cleared by the FDA?
Accuscan Microbead Standards (K902294) received a 510(k) decision of Substantially Equivalent on July 3, 1990, 42 days after the submission was received.
What is the product code of K902294?
The FDA product code is JIW – Calibrator, Surrogate, a Class II (moderate risk) device regulated under 21 CFR 862.1150.