Veigert's Iron Hematoxylin STAIN-HT10-79
FDA 510(k) K833424 · Sigma Chemical Co.
510(k) numberK833424
Submission
- Device name
- Veigert's Iron Hematoxylin STAIN-HT10-79
- Applicant
- Sigma Chemical Co.
Mchenry, IL, US - Received
- October 3, 1983
- Decision date
- November 3, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HYO – Hematoxylin Weigert'S
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
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Questions and answers
When was Veigert's Iron Hematoxylin STAIN-HT10-79 cleared by the FDA?
Veigert's Iron Hematoxylin STAIN-HT10-79 (K833424) received a 510(k) decision of Substantially Equivalent on November 3, 1983, 31 days after the submission was received.
What is the product code of K833424?
The FDA product code is HYO – Hematoxylin Weigert'S, a Class I (low risk) device regulated under 21 CFR 864.1850.