Harris Hematoxylin, Mercury Free, Acid
FDA 510(k) K843425 · Accra Laboratories, Inc.
510(k) numberK843425
Submission
- Device name
- Harris Hematoxylin, Mercury Free, Acid
- Applicant
- Accra Laboratories, Inc.
Mchenry, IL, US - Received
- September 4, 1984
- Decision date
- October 2, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HYK – Hematoxylin Harris'S
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code HYK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K873107 | Instant HematoxylinHYK · Traditional | Shandon, Inc. | 08/21/1987SE |
| K872498 | Harris HematoxylinHYK · Traditional | Anatech, Ltd. | 07/09/1987SE |
| K823328 | Harris HematoxylinHYK · Traditional | Accra Laboratories, Inc. | 12/28/1982SE |
| K810733 | Harris HematoxylinHYK · Traditional | Surgipath | 04/14/1981SE |
| K800324 | Volu-Sol Harris HematoxylinHYK · Traditional | Volu Sol Medical Industries | 02/22/1980SE |
| K781585 | Hematoxylin Stain HarrisHYK · Traditional | Bioscientific | 10/10/1978SE |
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| 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 |
| K843428 | BiofixLDZ · Traditional | 09/27/1984SE |
| K843426 | Eosin Y 1% AlcoholicHYB · 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 Harris Hematoxylin, Mercury Free, Acid cleared by the FDA?
Harris Hematoxylin, Mercury Free, Acid (K843425) received a 510(k) decision of Substantially Equivalent on October 2, 1984, 28 days after the submission was received.
What is the product code of K843425?
The FDA product code is HYK – Hematoxylin Harris'S, a Class I (low risk) device regulated under 21 CFR 864.1850.