Bio Sure Stain
FDA 510(k) K832496 · Helena Laboratories
510(k) numberK832496
Submission
- Device name
- Bio Sure Stain
- Applicant
- Helena Laboratories
Mchenry, IL, US - Received
- July 27, 1983
- Decision date
- September 12, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IDA – Alcian Blue
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code IDA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K801143 | Volu-Sol Urinary Dichrome StainIDA · Traditional | Volu Sol Medical Industries | 05/30/1980SE |
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Questions and answers
When was Bio Sure Stain cleared by the FDA?
Bio Sure Stain (K832496) received a 510(k) decision of Substantially Equivalent on September 12, 1983, 47 days after the submission was received.
What is the product code of K832496?
The FDA product code is IDA – Alcian Blue, a Class I (low risk) device regulated under 21 CFR 864.1850.