Sigms B-Hydroxybutarate Procedure No. 310-UV
FDA 510(k) K850368 · Sigma Chemical Co.
510(k) numberK850368
Submission
- Device name
- Sigms B-Hydroxybutarate Procedure No. 310-UV
- Applicant
- Sigma Chemical Co.
St. Louis, MO, US - Received
- January 31, 1985
- Decision date
- August 30, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIN – Nitroprusside, Ketones (Urinary, Non-Quant.)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1435
- Specialty
- Clinical Chemistry
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Questions and answers
When was Sigms B-Hydroxybutarate Procedure No. 310-UV cleared by the FDA?
Sigms B-Hydroxybutarate Procedure No. 310-UV (K850368) received a 510(k) decision of Substantially Equivalent on August 30, 1985, 211 days after the submission was received.
What is the product code of K850368?
The FDA product code is JIN – Nitroprusside, Ketones (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1435.