Eosin Y Solution Alcholic
FDA 510(k) K821573 · Sigma Chemical Co.
510(k) numberK821573
Submission
- Device name
- Eosin Y Solution Alcholic
- Applicant
- Sigma Chemical Co.
Mchenry, IL, US - Received
- May 27, 1982
- Decision date
- June 9, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HYB – Eosin Y
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code HYB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K893663 | Instant Eosin-AqueousHYB · Traditional | Shandon, Inc. | 06/13/1989SE |
| K880596 | Eosin Y Solution, Alcoholic, with PhloxineHYB · Traditional | Sigma Chemical Co. | 03/31/1988SE |
| K880240 | Instant Eosin-AlcoholicHYB · Traditional | Shandon, Inc. | 03/03/1988SE |
| K843426 | Eosin Y 1% AlcoholicHYB · Traditional | Accra Laboratories, Inc. | 09/27/1984SE |
| K822982 | Midas 100 Hemacolor Stain #66030HYB · Traditional | Emd Chemicals, Inc. | 10/27/1982SE |
| K821574 | Eosin Y Solutin, AgueousHYB · Traditional | Sigma Chemical Co. | 06/10/1982SE |
| K811797 | Eosin-YHYB · Traditional | Richard-Allan Medical Ind., Inc. | 07/28/1981SE |
| K811826 | Eosin YHYB · Traditional | Surgipath | 07/10/1981SE |
| K800942 | Volu-Sol Eosin Y StainHYB · Traditional | Volu Sol Medical Industries | 05/08/1980SE |
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| K933678 | Sigma Calcium ReagentCJY · Traditional | 03/11/1994SE |
| K933696 | Sigma Electrolyte Reference ReagentJFL · Traditional | 01/03/1994SE |
| K933691 | Sigma CO2 Alkaline Buffer ReagentJFL · Traditional | 12/17/1993SE |
| K933679 | Sigma Bun ReagentLFP · Traditional | 12/17/1993SE |
| K933703 | Sigma Wash Concentrate SolutionJJE · Traditional | 12/10/1993SE |
| K933692 | Sigma CO2 Acid ReagentJFL · Traditional | 12/09/1993SE |
| K933695 | Sigma Electrolyte BufferJFL · Traditional | 10/22/1993SE |
| K933697 | Sigma Cre ReagentCGX · Traditional | 10/18/1993SE |
| K933693 | Sigma CX-3 Calibration Standard Level 2JIX · Traditional | 10/13/1993SE |
Questions and answers
When was Eosin Y Solution Alcholic cleared by the FDA?
Eosin Y Solution Alcholic (K821573) received a 510(k) decision of Substantially Equivalent on June 9, 1982, 13 days after the submission was received.
What is the product code of K821573?
The FDA product code is HYB – Eosin Y, a Class I (low risk) device regulated under 21 CFR 864.1850.