Eosin Y 1% Alcoholic
FDA 510(k) K843426 · Accra Laboratories, Inc.
510(k) numberK843426
Submission
- Device name
- Eosin Y 1% Alcoholic
- Applicant
- Accra Laboratories, Inc.
Mchenry, IL, US - Received
- September 4, 1984
- Decision date
- September 27, 1984
- 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 |
| 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 |
| K821573 | Eosin Y Solution AlcholicHYB · Traditional | Sigma Chemical Co. | 06/09/1982SE |
| 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 |
More from Volu Sol Medical Industries
| 510(k) | Device | Decision |
|---|---|---|
| K851494 | Two-Step Acid Fast Bacteria StainJTS · Traditional | 04/29/1985SE |
| K851493 | Kinyoun Acid Fast Stain KitJTS · Traditional | 04/29/1985SE |
| K843427 | Gill Papanicolaou Stain EA-1 & 2 OG-6HZJ · Traditional | 10/02/1984SE |
| K843425 | Harris Hematoxylin, Mercury Free, AcidHYK · Traditional | 10/02/1984SE |
| K843428 | BiofixLDZ · Traditional | 09/27/1984SE |
| K843429 | Gram Stain Set W/Stabilized IodineJTS · Traditional | 09/14/1984SE |
| K831090 | Hematoxylin Gill Formulation IX#56016HYJ · Traditional | 06/08/1983SE |
| K830542 | Hemaquik II Staining Solution #55961IAF · Traditional | 03/17/1983SE |
| K823329 | Papincolabu Stain EA-36/50/65 & OG-6HZL · Traditional | 12/28/1982SE |
| K823328 | Harris HematoxylinHYK · Traditional | 12/28/1982SE |
Questions and answers
When was Eosin Y 1% Alcoholic cleared by the FDA?
Eosin Y 1% Alcoholic (K843426) received a 510(k) decision of Substantially Equivalent on September 27, 1984, 23 days after the submission was received.
What is the product code of K843426?
The FDA product code is HYB – Eosin Y, a Class I (low risk) device regulated under 21 CFR 864.1850.