Elastic Stain
FDA 510(k) K864074 · Sigma Diagnostics, Inc.
510(k) numberK864074
Submission
- Device name
- Elastic Stain
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- October 20, 1986
- Decision date
- October 29, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IAC – Van Gieson'S Stain
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
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Questions and answers
When was Elastic Stain cleared by the FDA?
Elastic Stain (K864074) received a 510(k) decision of Substantially Equivalent on October 29, 1986, 9 days after the submission was received.
What is the product code of K864074?
The FDA product code is IAC – Van Gieson'S Stain, a Class I (low risk) device regulated under 21 CFR 864.1850.