Creatinine Standard #65072
FDA 510(k) K822477 · Emd Chemicals, Inc.
510(k) numberK822477
Submission
- Device name
- Creatinine Standard #65072
- Applicant
- Emd Chemicals, Inc.
Mchenry, IL, US - Received
- August 17, 1982
- Decision date
- September 17, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIS – Calibrator, Primary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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Questions and answers
When was Creatinine Standard #65072 cleared by the FDA?
Creatinine Standard #65072 (K822477) received a 510(k) decision of Substantially Equivalent on September 17, 1982, 31 days after the submission was received.
What is the product code of K822477?
The FDA product code is JIS – Calibrator, Primary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.