Amyloid Stain, Congo Red HT 60
FDA 510(k) K840798 · Sigma Chemical Co.
510(k) numberK840798
Submission
- Device name
- Amyloid Stain, Congo Red HT 60
- Applicant
- Sigma Chemical Co.
Mchenry, IL, US - Received
- February 23, 1984
- Decision date
- March 12, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ICH – Congo Red
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
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Questions and answers
When was Amyloid Stain, Congo Red HT 60 cleared by the FDA?
Amyloid Stain, Congo Red HT 60 (K840798) received a 510(k) decision of Substantially Equivalent on March 12, 1984, 18 days after the submission was received.
What is the product code of K840798?
The FDA product code is ICH – Congo Red, a Class I (low risk) device regulated under 21 CFR 864.1850.