Reagent System
FDA 510(k) K760821 · Sigma Chemical Co.
510(k) numberK760821
Submission
- Device name
- Reagent System
- Applicant
- Sigma Chemical Co.
Mchenry, IL, US - Received
- October 13, 1976
- Decision date
- October 21, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CJT – Hydrazone Colorimetry, Aldolase
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1040
- Specialty
- Clinical Chemistry
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| K933695 | Sigma Electrolyte BufferJFL · Traditional | 10/22/1993SE |
| K933697 | Sigma Cre ReagentCGX · Traditional | 10/18/1993SE |
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Questions and answers
When was Reagent System cleared by the FDA?
Reagent System (K760821) received a 510(k) decision of Substantially Equivalent on October 21, 1976, 8 days after the submission was received.
What is the product code of K760821?
The FDA product code is CJT – Hydrazone Colorimetry, Aldolase, a Class I (low risk) device regulated under 21 CFR 862.1040.